Abstract of the thesis entitled An evidence-based ... Lai Fan.pdf · Abstract of the thesis...

I

Abstract of the thesis entitled

An evidence-based guideline of performing massage by labour

companion to improve labour outcomes

Submitted by

TSE LAI FAN

For the Degree of Master of Nursing

At the University of Hong Kong

In August 2015

The number of labouring women using pharmacological pain relief methods had

increased dramatically in recent years. However, the pharmacological pain relief

methods not only bring side effects on labour women but also on the newborns. In

order to improve labouring women pain relief process, there is a need to develop a

comprehensive, user friendly and evidence-based guideline for promoting massage as

a non-pharmacological pain relief method for relieving labour pain. Traditional

pharmacological pain relief methods are associated with different side effects such as

nausea and vomiting on maternal and respiratory distress on neonatal. Recent

researches documented that using massage which performed by labour companions

not only can reduce labour pain but also reduce anxiety and increase satisfaction of

labouring women. Therefore, this translational research aims to evaluate the current

practice on the effect of adopting massage program to formulate an evidence-based

guideline, assess its implementation potential and to develop an implementation and

evaluation plan.

II

Five selected literature were retrieved from three electronic bibliographic databases.

In order to ensure the quality and validity of the selected evidences, critical appraisal

had been done. Based upon the information from the identified literature, a clinical

guideline is developed. The implementation potential is assessed based on the

similarity and the readiness of the target setting to the proposed environment. The

transferability of the protocol was high and it was feasible to be implemented into the

target ward.

An implementation plan was then planned which included the communication plan

with all the stakeholders. A pilot study will be carried out for examining the readiness

before the full scale implementation of the program after reaching a consensus among

the stakeholders.

The evaluation plan of the effectiveness of the proposed program is developed. The

implementation of this labour companion-led massage program is suggested to be

worthy of adopting in the clinical setting for bringing benefits such as decreasing

labour pain or anxiety to labouring women, decreasing the workload to the staff and

decreasing expenditure on pharmacological pain relief in the hospital.

III

An evidence-based guideline of performing massage

by labour companion to improve labour outcomes

By

TSE LAI FAN

(B. Nurs. H.K.U.)

A thesis submitted in partial fulfillment of the requirement for

the Degree of Master of Nursing

at the University of Hong Kong

August, 2015

IV

Declaration

I declare that this dissertation represents my own work, except where due

acknowledgment is made, and that is has not been previously included in a thesis,

dissertation or report submitted to this university or to any other institution for a

degree, diploma or other qualifications.

Signed:

TSE LAI FAN

V

Acknowledgment

I would like to show my sincere gratitude to my supervisor Dr. Patsy Chau for her

patient guidance and the long way support in my dissertation in these two years. Dr.

Chau’s insightful comments and suggestions enable me to complete this dissertation

successfully. Thank you very much Dr. Chau.

I would also like to thank my classmates for their support in the past two-year of study.

I have had a fruitful time in studying master. Last but not the least, I would like to

thanks my family and my fiance for their continuous encouragement and backup in

my life which making it goes smooth and delighted.

1

Table of Content

Abstract ...........................................................................................I-II

Declaration.......................................................................................IV

Acknowledgments............................................................................V

Table of Content...............................................................................1

Abbreviation.....................................................................................6

Chapter 1 introduction

1.1 Background................................................................................7

1.2 Affirming needs.........................................................................10

1.3 Aim............................................................................................12

1.4 Objectives..................................................................................12

1.5 Significance...............................................................................12

Chapter 2 Critical appraisal

2.1 Search and appraisal strategies.................................................14

2.1.1 Identification of studies.........................................................14

2.1.2 Inclusion criteria....................................................................14

2.1.3 Data extraction.......................................................................15

2.1.4 Appraisal strategies................................................................15

2.2 Summary of the data.................................................................16

2.2.1 Search result...........................................................................16

2

2.2.2 Level of evidence...................................................................17

2.2.3 Patients characteristics...........................................................18

2.2.4 Intervention............................................................................19

2.2.5 Control...................................................................................19

2.2.6 Outcome measures.................................................................20

2.3 Summary of results...................................................................20

2.4 Synthesis...................................................................................21

Chapter 3 Translation and application

3.1 Implementation potential.........................................................24

3.2 Transferability of the findings..................................................24

3.2.1 Target setting.........................................................................24

3.2.2 Target audience......................................................................25

3.2.3 Philosophy of care.................................................................26

3.2.4 Periods for implementation and evaluation...........................26

3.3 Feasibility of the innovation.....................................................27

3.3.1 Manpower..............................................................................27

3.3.2 Multi-discipline co-operation................................................28

3.3.3 Tools for evaluation...............................................................28

3.4 Costs and benefits.....................................................................29

3.4.1 Individual benefits and risks..................................................29

3.4.2 Material costs of the institution.............................................31

3

3.5 Establishing evidence based practice guideline.......................32

3.5.1 Evidence based guideline/Protocol development.................32

Chapter 4 Implementation plan

4.1 Identifying of stakeholders......................................................34

4.1.1 Frontline users of the ward...................................................34

4.1.2 Management level of the department...................................35

4.1.3 Administrative level of the hospital.....................................35

4.2 Communication plan...............................................................35

4.2.1 Initiation phase.....................................................................36

4.2.2 Facilitating phase..................................................................37

4.2.3 Sustaining phase...................................................................38

4.3 Pilot study plan........................................................................38

4.3.1 Participants ..........................................................................38

4.3.2 Procedure..............................................................................39

4.4 Evaluation plan........................................................................39

4.4.1 Patient outcome....................................................................40

4.4.2 Health care procedures outcome...........................................40

4.4.3 System outcome....................................................................41

4.5 Nature of patients to be involved.............................................41

4.6 Determining the number of clients..........................................41

4.7 Data analysis............................................................................42

4

4.8 Basis for an effective change of practice...........................................42

Chapter 5 Conclusion...............................................................................44

Appendices

Appendix 1 Search strategies...................................................................45

Appendix 2 Flow diagram of the systematic search................................46

Appendix 3 Tables of evidence................................................................47

Appendix 4 SIGN critical appraisal checklist .........................................52

Appendix 5 VAS for pain level................................................................53

Appendix 6VAS for anxiety level............................................................54

Appendix 7 Set up cost for massage therapy...........................................55

Appendix 8 Estimated currents costs for massage therapy......................56

Appendix 9 Estimated savings for massage therapy................................58

Appendix 10 An evidence based protocol on massage therapy...............59

Appendix 11 Key to evidence statements and

grades of recommendation.......................................................................69

Appendix 12 Estimated schedule for implementation

and evaluation..........................................................................................70

Appendix 13 Labouring women satisfaction survey (English

version).....................................................................................................72

Appendix 14 Labouring women satisfaction survey (Chinese version)...73

Appendix 15 Staff satisfaction survey......................................................74

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Appendix 16 Staff survey on acceptance of EBP guidelines................75

References.............................................................................................76

6

Abbreviation and Symbols

Abbreviation

APN Advanced Practice Nurse

COS Chief of Service

DOM Department of Manager

EBP Evidence based practice

NO Nursing Officer

VAS Visual Analogue Scale

WM Ward Manager

Symbols

% Percentage

e.g. Example

7

Chapter 1 Introduction

1.1 Background

Childbirth is a unique experience. It contains happiness, stress, fear, pain, fatigue and

negative moods. Among them, pain is an inevitable part of labour as well as the most

irritating part of child birth. Pain level is correlated to the increasing of cervical

dilation and the frequency of the uterine contraction. The stages of labour include

three stages: first, second and third stage. For the first stage of labour, starts with the

regular uterine contractions and cervix becomes shorten until reaches 10-cm (Lowe,

2002). In this stage, the pain is caused by mechanical stretching from the lower

uterine segment, the cervical tissue stretching during dilation and pressure on the

adjacent structures and nerves. During this stage, women usually can tolerate the pain

well and require less pharmacological and non-pharmacological pain relief methods.

For the second stage of labour, the cervix is fully dilated and the baby is born (Lowe,

2002). In this stage, pain comes from the distention of vaginal wall, traction of pelvic

floor and stretching from the perineum muscle. During this stage, women usually

experience more pain and require for stronger pain relief methods. For third stage of

labour, it starts from the baby out to the delivery of the placenta. The pain is caused

by the uterine contractions to separate the placenta from the uterus and squeeze the

placenta out of the vagina. At this stage, women do not require for any pain relief

methods. When the labour progresses to advanced stage and causes increasing

intensity of labour pain, women become more and more anxious and fear. As a result,

emotion is involved and a negative birth experience is brought out (Ip, W. Y. 2000).

Bertsch et al. (1990) reported that a negative birth experience was brought out when

husbands talked and touched less to the laboring women during labour. The labour

companions especially husbands voted by the laboring women as the increasing the

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meaning of labour experience, since the labour companions accompany with the

labouring women for their whole labour process. Thus the labour companions were

closely related to the birth experience of laboring women (Ip, W. Y. 2000).

On the other hand, Mohta, Sethi, Tygi and Mohta (2003) stated that psychological

aspect is as important as the physical care. Evidence based on nursing care shows that

the psychological aspect of patient care is important (Cooke et al., 2005). Anxiety is a

co-existing factor with labour pain when women in their labour, Anxiety can be

defined as the subjective emotions of people experiencing an unfavorable situation

and it would cause physical changes like elevate blood pressure and palpitation (Alan,

2000). Therefore, anxiety of laboring women not only affects their physical but also

psychological status such as psychological satisfaction. Besides, anxiety also

interferes with the duration of labour and induces a longer duration of labour pain

(Gallo et al., 2013).

Hence, there are various pain relief methods which include pharmacological and

non-pharmacological for relieving labour pain in different stages of labour. The

pharmacological pain relief methods include injection of medication such as Pethidine,

inhalation of Entonox, administration of spinal analgesia and so on. However, these

various pharmacological pain relief methods not only bring many side effects on

women but also on newborns. After injection of Pethidine, majority of women

complain they are suffering from nausea, vomiting, dizziness and so on. Furthermore,

if they give birth within four hours after injection of Pethidine, the newborns are at

high risk of neonatal respiratory depression (McCaffery & Beebe, 1989; Mobily, et al.,

1994). So, the non-pharmacological pain relief methods such as breathing exercise,

9

birth ball, music therapy, massage therapy and so on become more and more popular

in labour pain relief.

According to different stages of labour, there are various non-pharmacological pain

relief methods could be used. During the latent phase of first stage of labour, women

can walk or move freely and experience less pain, therefore, breathing exercise and

birth ball could be used for pain relief (Royal College of Midwives, 2002). When the

labour progresses into more advanced stage of labour, women experience more severe

labour pain, at that time, they cannot control their breathing easily or they cannot

move easily from the birth ball exercises. Therefore, massage become more common

in relieve labour pain in active phase of labour. Massage not only could be

administered by different persons such as midwives or labour companions but also

could be administered to laboring women when they are in different position such as

supine position or side lying position (Field et al., 1999).

Massage is an ancient technique which widely performed during labour to reduce

labour pain in western countries such as Australia (Keenan, 2000). Midwives in the

western countries point out that massage can decrease the severity of pain, relieving

muscle spasm and promoting general relaxation (Brown et al., 2001). There has been

comprehensively and marked decrease in women in labour pain for many years has

been demonstrated (Gallo et al., 2013). Mechanisms of massage can work through

two different pathways: either blocking the pain impulse by the A-fibers transfer or

stimulating the locally released endorphin (Chang et al., 2002). In addition, massage

provides physical contact with the labour companions, promote relaxation and reduce

stress emotion. Richardoon (1984) stated that appropriate contact can help to relieve

10

pain and maintain a sense of body boundary intactness. Furthermore, the potential

benefits of massage include decreasing the intensity of pain, relieving muscle spasm

and decreasing anxiety. Massage administered by labour companions could influence

laboring women reaction to pain, made them feel safer and calmer (Brown, 2001).

1.2 Affirming needs

In obstetric wards in Hong Kong, the usual pain relief methods for relieving labour

pain are mainly on pharmacological methods such as inhalation of Entonox and

injection of Pethidine. Although non-pharmacological pain relief methods are also

used by laboring women, massage therapy is new to the laboring women.

The local setting is Ward A of the Obstetric & Gynecological Department (O&G) in a

public hospital in Hong Kong, the trained midwives provide both pharmacological

and non-pharmacological pain relief methods such as breathing exercises, birth ball

and music therapy. There were total 8160 deliveries in year 2013 in Ward A. 85%

women choose injection Pethidine or inhalation of Entonox as their pain relief

methods since these methods have fast acting on relieving pain. Massage as a

non-pharmacological pain relief method. It is available in Ward A but it is only

administered to labouring women by physiotherapists. When the physiotherapists are

occupied, massage cannot be administered.

Meanwhile, due to the heavy workload in ward A, midwives usually focus on the

physical care and specific procedures for women. The psychological aspects such as

anxiety or psychological satisfaction of women are often ignored.

Labour companions present in labour are common in Ward A. Laboring women

11

psychological satisfaction is correlated to the presence of labour companions. Labour

companions can be defined as the people who accompany with women during labour.

They are usually husbands, physiotherapists or registered massage therapists and so

on. Kenian and Hobfall (1989) had pointed out that the presence of labour

companions does not necessarily help laboring women to cope better. However, the

support during labour is useful when the labour companions are able to help the

laboring women to meet their needs during labour such as relieving pain by massage.

In the first stage of labour, the labour companions’ presences give practical support to

the laboring women. The labour companions stay with women longer time, they can

offer more practical help. It is reasonable that the first stage of labour is usually a long

and painful for the laboring women, therefore, they need more practical help and

support at this time. Therefore, during the labour, labour companions not only provide

physical but also psychological care such as support to women. In addition, research

findings reported that support from labour companions during labour is conducive to a

more positive experience of childbirth, shorter duration of labour and a positive

attitude towards growing into motherhood (Beaton & Gupton, 1990; Koeske &

Koeske, 1990; Pascoe & French, 1990). Hence, labour companions would be the best

person to administer massage therapy to the labouring women.

Massage is a good labour pain relief method because it is a non-invasive technique; it

has the least possible side effects for women and newborns, prolonged pain relief

effect, easy to administer and has appropriate sedative without affect the uterine

contractions. In addition, massage administered by labour companions to the laboring

women not only reduce the anxiety level in laboring women but also improved the

psychological support and satisfaction of them. However, there is a lack of evidence

12

among midwives and labouring women on massage therapy in pain relief or reduction

anxiety. Thus, this leads to massage therapy is new to as a pain relief method.

Therefore, massage administered by labour companions to laboring women may

relieve pain or anxiety of the labouring women in the local setting.

1.3 Aim

The aim of this dissertation is to develop an evidence-based guideline of performing

massage by labour companions to labouring women so as to improve labour

outcomes.

1.4 Objectives

1) To review, summarize and synthesis current evidences.

2) To determine the transferability and feasibility of performing massage by labour

companions in local setting and generate a set of guideline for using massage on

labouring women in labour ward.

3) To develop an implementation plan and evaluation plan for the proposed

innovation.

1.5 Significance

This dissertation implies the use of massage administered by labour companions to

either relieving labour pain or anxiety in labouring women. Pharmacological pain

relief methods such injection of Pethidine or Inhalation of Entonox and

non-pharmacological pain relief methods such breathing exercises, birth ball or music

therapy are the main pain relief methods in Hong Kong. While these pain relief

methods can relieve pain, they cannot provide support for the labouring women

13

during the labour process. In contrast, massage therapy not only provide pain relief

but also provide psychological support for the labouring women, let them would not

feel alone during their labour. However, massage as a pain relief method but it is new

to midwives. Moreover, nursing intervention puts too much emphasis on

pharmacological relief methods. Therefore, massage as an alternative method to

relieve labour would be investigated. The massage therapy not only relieve labour

pain without any side effects but also provide relaxation to women during labour, as a

result, the anxiety level is reduced. Meanwhile, since the labour companions

administered massage therapy to the labour women, their satisfaction is increased. So,

massage therapy is worth to utilizing as a pain relief for labouring women.

14

Chapter 2 Critical appraisal

2.1 Search and appraisal strategies

2.1.1 Identification of Studies

A systematic approach was used to identify relevant research studies. The three

databases used were PubMed, CINAHL plus and PsycINFO. There were four groups

of keywords included. The first group was the intervention includes ‘massage’ or

‘massage therapy’ or ‘birth massage’. The second group was ‘labour obstetric’ or

‘parturition’. The third group was ‘labour pain’ or ‘labor pain’. The fourth group was

‘anxiety’ or ‘anxious’ or ‘stress’. The search operator ‘AND’ was used between

groups in order to identify reference including at least on instance from each of the

three groups of keywords or concepts. However, since the labour pain and anxiety

were the two outcome measures, therefore, the search operator ‘OR’ was used to

connect them. Each database was used to screen search results. Hence, relevant

references were collected and duplicated results were combined. In order to extract

more journal articles, a further manual search of the reference lists of the initially

identified studies was done.

2.1.2 Inclusion criteria

The inclusion criteria were:

Randomized Controlled Trial (RCT)s or Clinical Controlled Trials;

Massage was done by labour companions in labouring women started at the first

or second stage of labour

The massage therapy was done by labour companions in the first stage of labour

because at this stage, women do not start delivery yet. In this stage, labour

companions can provide the appropriate massage to the target subjects according to

15

the labour pain. It is not feasible to perform massage for women after delivery, as the

clients need a rest or receive other treatments.

The exclusion criteria were:

Women who have medical, obstetric or psychiatric complications;

Women have cesarean section;

Women do not have labour companions.

2.1.3 Data extraction

The search was performed on 5th August, 2014. The first screened were the title and

abstracts of the resulting citations. If the articles match the selection criteria, full text

of papers and their references lists would be reviewed.

The table of evidence is constructed according to the Scottish Intercollegiate

Guidelines Network (SIGN) (2012). The table of evidence included: bibliographic

citation, study design, characteristics of subjects, intervention, comparison and effect

size.

2.1.4 Appraisal strategies

An appraisal tool named Scottish Intercollegiate Guideline Networks (SIGN)

developed by the National Health Service (NHS) was used to assess the quality of the

selected articles. Studies were evaluated with regard to the following criteria which

including ‘appropriateness and clarify of the focus question’, ‘randomization method’,

‘concealment method’, ‘blinding’, ‘similarity at the start of the trial’, ‘different

between groups is the treatment under investigation’, ‘standard measure’, ‘dropout

rate’, ‘intention to treat’, and ‘carried and compared at different sites’.

16

2.2 Summary of the data

2.2.1 Search result

After reviewed all the related papers, five papers (Chang et al., 2002; Karami et al.,

2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013) were selected as

the evidence. Search details and flow diagram of the systematic search are listed in

Appendix 1 and 2. Data from five papers were extracted to a table of

evidenceAppendix3. These five studies were carried out at Taiwan (Chang et al.,

2002), Tehran (Karami et al., 2007; Mortazavi et al., 2012), Canada (Janssen et al.,

2012) and Brazil (Gallo et al., 2013). All these studies were conducted in labour ward

(Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012, Janssen et al., 2012;

Gallo et al., 2013). Three were randomized controlled trial studies (Chang et al., 2002;

Janssen et al., 2012; Gallo et al., 2013) and two were clinical controlled trial studies

(Karami et al., 2007; Mortazavi et al., 2012). For the randomized controlled trials

studies, Chang et al. (2002) used four balls for the randomization. Two balls were

marked E for the experimental group and the other two balls were marked C for the

control group. Janssen et al. (2012) used a random seed generated the sequential

number for the experimental and control group. Gallo et al. (2013) used a computer

-generated random allocation list to randomly assigned experimental or control group.

Both Karami et al. (2007) and Mortazavi et al. (2012) were clinical controlled trials so

they did not have randomization.

In these five studies, the sample size ranged from 46 to 120. Three studies power

calculation for their sample size (Chang et al., 2002; Janssen et al., 2012; Gallo et al.,

2013). Although these three studies used power calculation, the sample size relatively

small (Chang et al., 2002; Janssen et al., 2012; Gallo et al., 2013). Two studies did not

17

mention power calculation for their sample size (Karami et al., 2007; Mortazavi et al.,

2012).

All selected articles showed statistically significant results for the intervention (Chang

et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et

al., 2013).

2.2.2 Level of evidence

The quality assessments of five studies were detailed illustrated in Appendix 4. Three

studies were rated ‘++’ because of high quality (Chang et al., 2002; Janssen et al.,

2012; Gallo et al., 2013). One study was rated ‘+’ because of medium quality

(Mortazavi et al., 2012). The remaining study was rated ‘－’ because of low quality

(Karami et al., 2007).

Five studies were addressed research question clearly and appropriately (Chang et al.,

2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al.,

2013). Three studies clearly illustrated the randomization method and approved

ethically (Chang et al., 2002; Janssen et al., 2012; Gallo et al., 2013). The two

remaining studies did not mention the randomization method (Karami et al., 2007;

Mortazavi et al., 2012). The blinding process only addressed in threes studies (Chang

et al., 2002; Janssen et al., 2012; Gallo et al., 2013). The remaining two studies did

not mention the blinding process (Karami et al., 2007; Mortazavi et al., 2012). The

treatment and control groups are similar at the start of the trial in five studies (Chang

et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et

al., 2013). Demographic data and characteristic of both groups were provided in five

studies (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et al.,

18

2012; Gallo et al., 2013). In five studies, p-value was determined by the statistical

testing showed that there was no significant difference in demographic characteristics

between intervention and control group (Chang et al., 2002; Karami et al., 2007;

Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013).

All subjects in the same group were treated equally in five studies. Outcomes

measured in a standard, valid and reliable way in five studies. Dropout rate was well

or adequately covered in five studies and the dropout rate was 2% (Chang et al., 2002;

Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013).

Three studies were well applied the ‘intention to treat’ analysis (Chang et al., 2002;

Janssen et al., 2012; Gallo et al., 2013). Two studies were not addressed the ‘intention

to treat’ issue (Karami et al., 2007; Mortazavi et al., 2012). Five studies were carried

out in one site only, carried and compared in different sites were not applicable in

these five studies.

2.2.3 Patient characteristics

Age range of the laboring women was from 16 to 36 years. All studies were women

have their first pregnancy with singleton (Chang et al., 2002; Karami et al., 2007;

Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). The five studies had

the same inclusion criteria including they were randomized controlled trial or

controlled trial studies, participants, subjects have labour companions. Subjects had

medical, obstetrical or psychiatric history were excluded from these studies.

19

2.2.4 Intervention

Three studies performed massage by labour companions to laboring women started

from cervical dilation 3 to 4 cm (Chang et al., 2002; Mortazavi et al., 2012; Janssen et

al., 2012), one study performed massage by labour companions at the cervical dilation

4 to 5cm (Gallo et al., 2013) and one study performed massage by labour companions

at the cervical dilation 8cm (Karami et al., 2007). The duration of massage performed

varied from 30 minutes to five hours. Subjects from four studies were administered

massage by labour companions for 30 minutes at the first stage of labour (Chang et al.,

2002; Karami et al., 2007; Mortazavi et al., 2012; Gallo et al., 2013). Subjects from

one study performed massage by labour companions up to five hours (Janssen, et al.,

2012). There were different of labour companions to administer massage to the

laboring women. Subjects from four studies were administered massage by husband

(Chang et al., 2002; Mortazavi et al., 2012), a registered massage therapist (Janssen et

al., 2012) and physiotherapists (Gallo et al., 2013). One study did not mention the

massage performed by whom (Karami et al., 2007). Three studies stated that various

parts of body could be administered massage included hands, forearms, shoulders,

waist, sacrum and buttock (Chang et al., 2002; Karami et al., 2007; Mortazavi et al.,

2012). The parts of body which administered massage depended on women

preference. One study mentioned that the massage mainly administered at between

T10 and S4 which nerves corresponded to the paravertebral ganglia, delivery canal

and perineum (Gallo et al., 2013). The remaining one study did not mention the

location of massage (Janssen et al., 2012).

2.2.5 Control

Five studies treated control group in usual care according to the labour ward routine

20

care.

2.2.6 Outcome measures

The primary outcome measure was the change in pain severity at the end of the

intervention period. The secondary outcome measure was the change in anxiety level

and the personal satisfaction at the end of the intervention period. All studies clearly

defined the time frame of measuring the severity of pain (Chang et al., 2002; Karami

et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). On the

other hand, there were different measuring tools used to measure the pain severity.

Chang et al. (2002) and Mortazavi et al. (2012) stated that the labour pain was

measured by the self-reported present pain intensity (PPI) Scale. Two studies used the

visual analogue scale (VAS) as a measuring tool to measure the labour pain (Karami

et al., 2007; Gallo et al., 2013). Janssen et al. (2012) used the Short Form McGill pain

Questionnaire to measure the labour pain. For the anxiety level, two studies used the

visual analogue scale to measure the anxiety (Chang et al., 2002; Mortazavi et al.,

2012). However, the remaining three studies did not measure the anxiety level

(Karami et al., 2007; Janssen et al., 2012; Gallo et al., 2013). For the measuring

personal satisfaction level, the questionnaires were disturbed to laboring women in

one study (Chang et al., 2002). The remaining of studies did not clearly mention the

measuring of laboring women in their psychological satisfaction (Karami et al., 2007;

Mortazavi et al., 2012; Janssen et al.,2012; Gallo et al ., 2013).

2.3 Summary of results

Five studies reported that the labour pain in labouring women was significantly

reduced in the intervention group (Chang et al., 2002; Karami et al., 2007; Mortazavi

21

et al., 2012; Janssen et al., 2012; Gallo et al., 2013). Moreover, all studies showed that

the severity of pain significantly decreased when massage administered to laboring

women in latent and active phase of labour (Chang et al., 2002; Karami et al., 2007;

Mortazavi et al.,2012; Janssen et al., 2012; Gallo et al., 2013). For the anxiety level,

two studies mentioned that anxiety was significantly reduced in the laboring women

when they were administered massage by labour companions in latent and active

phase (Chang et al., 2002; Mortazavi et al., 2012). Moreover, the psychological

satisfaction of laboring women were higher after the massage administered (Chang et

al., 2002; Mortazavi et al., 2007). There was no complications of massage reported

from these studies (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012;

Janssen et al., 2012; Gallo et al., 2013).

2.4 Synthesis

Massage as an effective intervention to reduce the pain in laboring women has been

explored in different countries. Five studies focused on massage intervention in labour

ward. In five studies, the population range of age is 16 to 36 years which is applicable

for women in obstetric settings. All these five studies reported that the labour pain in

laboring women had significant reduction, meanwhile, the anxiety level in laboring

women also reduced. Therefore, these results could be generalized to the primiparous

women with singleton, no medical, obstetric or psychiatric complications and they are

in active labour.

In massage intervention used in these studies, there were different types of massage

such as Swedish massage. Three studies used Swedish massage (Karami et al., 2007;

Mortazavi et al., 2012; Janssen et al., 2012). Swedish massages were included

22

shoulder and back massage, abdominal effleurage and sacral pressure. The remaining

two studies did not mention the type of massage used (Chang et al., 2002; Gallo et al.,

2013). In addition, different parts of body could be administered massage such as

hands, forearms, waist, sacrum, buttocks or feet. The most common parts used to

administer massage were sacrum and buttocks in all studies (Chang et al., 2002;


The less common parts used to administer massage were hands, forearms and feet

(Janssen et al., 2012; Gallo et al., 2013). Five studies stated that both the types of

massage and locations of body to be administered massage depended on women

preferences (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et

al., 2012; Gallo et al., 2013). Furthermore, there is no standardization for whom to be

the labour companions to administer massage. The labour companions could be

husbands, registered massage therapists or physiotherapists (Chang et al., 2002;

Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). Hence, administered

massage for the women with comfortable position is needed to be considered.

The ideal duration of massage in most studies reported was 30 minutes due to the

prolonged performing massage would cause the fatigueless of the labour companions

(Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Gallo et al., 2013).

One remaining study stated that massage administered by labour companions could be

up to five hours during labour (Janssen et al., 2012). On the other hand, the duration

of massage could be adjusted with labouring women preferences (Chang et al., 2002;


The ideal time to start performing massage to reduce labour pain is when the cervical

dilation to 3-4 cm suggested by the studies (Chang et al., 2002; Mortazavi et al., 2012;

23

Gallo et al., 2013). Massage group had statistically significant lower pain state

compared with control group in first stage of labour (Chang et al., 2002; Karami et al.,

2007; Mortazavi et al., 2012, Janssen et al., 2012; Gallo et al., 2013). The massage

can provide sooth effect and leads women feel relaxed when they are in their latent. If

the massage started at more advanced stage of labour, the increased severity of labour

pain would adversely affect their anxiety level (Chang et al., 2002; Karami et al.,

2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013) .

In conclusion, a positive effect of massage administered to laboring women during

their active labour may not only could minimize their labour pain but also reduce their

anxiety, provide psychological support and increase their psychological satisfaction.

Although pain could not be totally eliminated, massage promotes the comfort and

psychologically support. The labour companions physical touch not only influence the

laboring women reaction to pain, but also make them feel safer and calmer. The most

important is to improve laboring women well-being during labour. Moreover, the

presences of labour companions serve encouragement, security and psychological

assurance for the laboring women, let the labouring women would not feel alone

during the labour process. As a result, laboring women could have a positive

experience of labour. Furthermore, there is no harmful or adverse effect in women or

neonatal. Thus, massage is safe and can be applied to laboring women.

24

Chapter 3 Translation and application

3.1 Implementation potential

After reviewing the five selected studies from chapter 2, it has been shown that

applying massage therapy to labouring women by labour companions is efficacious in

reduce pain or anxiety during labour. It is worth to consider translating the

corresponding evidence and applying it in Ward A. Before developing evidence-based

practice (EBP) guideline and implementing massage therapy to reduce labour pain or

anxiety in Ward A, there should be a thorough assessment of its implementation

potential. Transferability of findings, the feasibility of implementation and the cost/

benefit ratio of the intervention would be assessed (Polit & Beck, 2004).

3.2 Transferability of the findings

Transferability refers to how the proposed innovation fits and suits into the Ward A.

To assess the suitability of the massage therapy protocol in Ward A, the

demo-graphical characteristics of target population, philosophy of care and the

program flow between Ward A and the reviewed studies must be compared.

3.2.1 Target setting

Our target setting is Ward A in a public hospital in Hong Kong which provides

obstetric service and has to take care of numerous pregnant women every day.

According to the hospital statistics, the total number of deliveries in Ward A in 2013

was 8160. That means there are 680 deliveries in Ward A each month. There are three

sections in Ward A. The first section consists of two cubicles which can hold twelve

beds for pregnant women undergo obstetrician assessments, vaginal examination,

induction or augmentation of labour women who have their first stage of labour and

25

other procedures. The pharmacological and non-pharmacological pain relief methods

will be provided in these cubicles for women who have their first stage of labour

(Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012;

Gallo et al., 2013). The second section is an isolation room for women who have

infectious diseases such as tuberculosis and high fever cases. The third section is

delivery rooms which provide eight delivery beds for the labouring women to deliver

at the same time, meanwhile, non-pharmacological pain relief methods will also be

provided for women during their second stage of labour. The time for providing

pharmacological and non-pharmacological pain relief methods is similar with the

literatures (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et

al., 2012; Gallo et al., 2013).

3.2.2 Target audience

Basically, the characteristic of the patients were similar for both local and those

mentioned in the literatures in the first stage of labour (Chang et al., 2002; Karami et

al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). The age

ranges of women in Ward A are from 16 to 42 and included primiparous and

multiparous, 90% of primiparous women are aged at 16 to 36 in Ward A. The age

ranged from 16 to 36 and are primiparous in the selected papers (Chang et al., 2002;


Thus, the demographic characteristics of women in the Ward A should be similar to

those considered in the literatures. Around 82% of primiparous women with labour

companions will be benefit from the massage therapy each month. Hence, massage

therapy administered by labour companions should be considered to relieve pain or

anxiety in labouring women in Ward A.

26

3.2.3 Philosophy of care

Pain is inevitable physical feeling during labour. Pain is one of the most concerns in

the Ward A but the busy work load and heavy patient-load shorten the

midwife-to-client time available for communication and choose the most suitable pain

relief for the labouring women to relieve their pain. The health care professionals’

primary focuses mainly on task-centered. Inadequate management of pain may affect

nursing quality of care and may increase the use of pharmacological pain relief which

will increase the fatal adverse effects on both maternal and neonatal outcomes

(Mortazavi et al., 2012; Gallo et al., 2013). According to the Code of Professional

Conduct and Code of Ethics from the Nursing Council of Hong Kong (2002),

midwives should provide a therapeutic environment and promote the less pain for the

laboring women. Midwives not only provide the best-possible services but also

wholehearted patient-centered care (“HA Code of Conduct”, 2009). In view of this,

the new program introduced is compatible to the philosophy of massage therapy in the

local setting which focus on relieve pain (Chang et al., 2002; Karami et al., 2007;

Janssen et al., 2012; Gallo et al., 2013) or anxiety (Chang et al., 2002; Mortazavi et al.,

2012) and promote a positive relationship between the laboring women and the labour

companions (Chang et al., 2002). Moreover, the massage therapy administered by

labour companions can help to reduce the vulnerabilities caused by pharmacological

pain relief methods to labouring women (Gallo et al., 2013).

3.2.4 Periods for implementation and evaluation

For this new program, the implementation and evaluation will be about 72 weeks.

Initial phase, including guideline and proposal development, seeking approval,

Formation of committee and organizing discussion groups will take 20 weeks. The

27

facilitating phase, including purchasing of the massage oil and organizing training

sessions for midwives, will take 12 weeks. In the sustaining phase, a pilot program

will be executed for 24 hours over four weeks, as the most committee members work

in different shifts. The women pain level or anxiety level, the acceptance and the

preference of massage therapy will be evaluated and analyzed in another 12 weeks.

Finally, an evaluation will take six months for data collection, analysis and evaluation.

Women will fill the evaluation forms for massage therapy in their postnatal. Midwives

would also fill a survey to evaluate the effectiveness of the intervention.

3.3 Feasibility of the innovation

3.3.1 Manpower

There are total 42 midwives in the Ward A and only ten of them have the

qualifications to perform massage therapy for the labouring women. The lack of

qualified trained midwives may affect the service quality provided for pain or anxiety

management. However, most of the untrained midwives are willing to commit

changes such as having training on massage therapy and studying evidence based

practice and providing better management in pain and anxiety. Suppose there will be

total three one-hour training sessions in three consecutive weeks, all midwives can be

trained within three weeks. In addition, a training session can be offered to new staff

annually.

Attitudes of the midwives are crucial for implementing an innovative program

(Alanen et al., 2009). Firstly, the Departmental Manager (DOM) and Ward Manager

(WM) advocate the midwives to use electronic database in intranet to update their

midwives knowledge. Meanwhile, the majority of midwives in Ward A recognize that

28

the pharmacological pain relief methods for labouring women is not good and higher

chance for the labouring women to suffer from respiratory and cardiovascular

complications such as drowsiness, lower blood pressure and neonatal complications

such as neonatal respiratory distress. These complications delay the labour process

and increase the time for resuscitation and workload for the midwives to close

monitor the labouring women. Therefore, midwives in Ward A are willing to explore

changes to improve this situation (Alanen, Valimaki & Kaila, 2009). Although there

might be slightly increase in workload for the midwives who undergo massage

therapy training, a probability of promotion will serve as an incentive for midwives to

participate.

3.3.2 Multi-discipline co-operations

Alanen (2009) stated that a good co-operation between midwives and other

disciplines such as physiotherapists or labour companions is a crucial factor for

implementing a new program successfully. In usual practice, only trained midwives

and physiotherapists to perform massage therapy for the labouring women in their

convenient time. But now, some of the physiotherapists are forming a group for

massage therapy. They are only ones who are responsible for administering massage

therapy to the labouring women. The DOM and the Ward Manager will hold a

meeting with the physiotherapists to discuss the issue including the advantages of

implementing this new programme and improve the communication between

midwives and physiotherapists. Midwives workload is likely increased because they

need to guide the labour companions to administer massage therapy to the labouring

women. Thus, the support from labour companions is also important. According to

Keinan & Hobfall (1989), lack of support from labour companions may increase

29

labour pain or anxiety in labouring women. Therefore, the labour companions, who

are usually the labouring women’s husband or relatives, are pleased to administer

massage therapy to the labouring women in order to provide some practical help

during labour (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen

et al., 2012; Gallo et al., 2013).

3.3.3 Tools for evaluation

As mentioned in the reviewed literatures, Visual Analogue Scale (VAS) was used for

labouring women to rate their pain and anxiety level (Chang et al., 2002; Karami et al.,

2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). The VAS record

charts for pain and anxiety are readily available in the Ward A. Details are shown in

Appendix 5 and 6.

3.4 Costs and Benefits

3.4.1 Individual benefits and risks

In Ward A, there are about 680 delivery cases each month, with 584 primiparous

delivery cases. According to the hospital statistics, with around 80% primiparous

labouring women with labour companions and around 82% primiparous cases with

labour companions are willing to provide massage therapy to the labouring women,

approximately around 383 cases are likely to benefit from participating in massage

therapy each month. The main benefits for implementing the new program are the

decrease their pain or anxiety during labour (Chang et al., 2002; Karami et al., 2007;

Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013).

Moreover, massage therapy as a non-pharmacological pain relief method can reduce

85% use of pharmacological pain relief methods and reduce 80% the risks of having

30

respiratory and cardiovascular complications for women and babies (Janssen et al.,

2012; Mortazavi et al., 2013).

It is relatively low risks for labouring women to receive this new program since the

massage therapy administered by trained labour companions would not cause any

harm (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et al.,

2012; Gallo et al., 2013). Therefore, this new program is safe for labouring women.

For the midwives, the instruction of administration of massage therapy is mainly the

source of increased workload for them. Midwives need to spend five minutes for

instructing the labour companions to perform massage. During labour, midwives

mainly focus on monitoring progress of labour. Nevertheless, job satisfaction of

midwives can be gained from the new program because labouring women are more

willing to establish a good rapport with them. However, the experienced trained

midwives will use extra time to hold the antenatal classes, their workload might be

slightly increased. They might be feeling stressed but a probability of promotion will

serve as an incentive for these midwives to participate.

For the obstetricians, less labouring women require pharmacological pain relief

methods such as Pethidine injection or spinal anesthesia to relieve labour pain after

the implementation of new program (Janssen et al., 2012; Gallo et al., 2013).

Labouring women are more willing to use massage therapy as a pain relief method

and thus reduce the chance of having complications from pharmacological pain relief

methods (Janssen et al., 2012; Gallo et al., 2013). Therefore, obstetricians are willing

to support the labouring women to use massage therapy to relieve pain and anxiety.

31

For the physiotherapists, some of them are forming a group which only responsible

for the midwife training sessions and administering massages therapy to labouring

women. The labour companions can share 90% workload for them. Therefore, they

are also willing to use massage therapy on labouring women to relieve pain and

anxiety.

3.4.2 Material costs of the institution

The total set up costs of massage program includes staff training, the salary of a

physiotherapist as a demonstrator and photocopies. A physiotherapist will be invited

three hours for training the midwives, the salary is $375 and 32 midwives using total

32 hours to attend the training sessions. The total cost of staff training will be $6000

and the photocopies will be $25.2. The total set up costs will be $6400.2. Details are

shown in Appendix 7. The recurrent costs of massage program include staff for data

collection and analysis, the midwives as the instructors and trainers who will do the

training in the antenatal classes and training session for new staff. The salary of staff

for data collection and analysis will be $7500 monthly. New staff training will be

$375 monthly. The antenatal classes will be $4500 monthly. The total recurrent costs

will be $18818.9 monthly.

The total set up costs and recurrent cost in the first year for massage program will be

approximately $232227(=$6400.2+ $18818.9 ×12).

Meanwhile, after implementation of this new program, according to the selected

literatures, 30% of labouring women use less 85% pharmacological pain relief

methods in their labour (Janssen et al., 2012; Gallo et al., 2013). That means in 383

32

eligible cases, 115 cases will use less 1 cylinder of Entonox which costs $600 for one

case. Thus, the cost in pharmacological pain relief methods is reduced $69000

monthly. Moreover, according to the reviewed literatures, about 30% of eligible cases

shorten duration of labour after receiving massage therapy (Karami et al., 2007;

Mortazavi et al., 2012). In addition, for the 383 eligible cases, physiotherapists can

save 30 minutes to administer massage in one case. The total man-power saved due to

administer massage to the labouring women among physiotherapists is 11490 minutes

monthly, of which the salary saving is about $23937.5. Details are shown in Appendix

9.

After calculating the above costs and benefits, the material benefits for implementing

this new program are $1115250(=$92937.5×12) in one year. The saving in the first

year already exceeds the set up cost plus the recurrent cost. Details are shown in

Appendix 9.

3.5 Establishing evidence based practice guideline

The proposed massage therapy administered by labour companions for labouring

women is transferable and feasible in the Ward A. It is also safe and cost-effective. An

evidence based practice (EBP) guideline will be developed to serve as guidance for

implementing the new intervention.

3.5.1 Evidence based guideline/ Protocol development

The Scottish Intercollegiate Guidelines Network (SIGN) (SIGN, 2012) was used to

develop the guideline (Appendix 11). Eleven recommendations were developed, all

were graded A which means a body of evidence in the selected studies can directly

33

applicable to the target population and demonstrating overall consistency of results.

Details of the protocol are shown in Appendix10.

34

Chapter 4 Implementation plan

The transferability and implementation potential of the innovation are discussed

previously. After developing the evidence-based guidelines, it is time to apply

massage intervention into practice. The next step would be a deliberate consideration

on the overall implementation plan. This could be accomplished through deciding the

communication plan, pilot testing and evaluation plan. The schedule of

implementation and evaluation is shown in Appendix 12 and will be discussed as

follows.

4.1 Identifying the stakeholders

The proposed innovation will be affected by the stakeholders. Ingersoll (2005)

claimed that identification of stakeholders is important as effective communication

can build up a positive cooperative relationship and gain their support throughout the

proposed program. Three levels of key stakeholders in this program including the

frontline users of the ward, management level of the department and administrative

level of the hospital.

4.1.1 Frontline users of the ward

The proposed protocol users were 42 midwives in the labour ward. Midwives can

make the decision of starting massage according to their professional judgments. They

are required to assist the labouring women in relieving labour pain or anxiety and

instruct labour companions to perform massage to labouring women. As midwives are

the users of the protocol, effective communication and detailed explanation of the

protocol to them is essential.

35

4.1.2 Management level of the department

Stakeholders in this group are the Chief of Service (COS), Department Operation

Manager (DOM) of the Obstetrics and Gynecology department, four Ward managers

(WM), five Nursing Officers (NO) and ten Advanced Practiced Nurses (APN). They

are experts in making clinical development and planning. Thus, seeking their approval

and support for the implementation of the new clinical guideline is essential. Besides,

positive staffs outcome and team spirit can be enhanced by the support from the

leader in a clinical environment (Ingersoll, 2005).

4.1.3 Administrative level of the hospital

Stakeholders in this group are the hospital Chief Executive Officer (CEO) and

General Manager of Nursing (GMN). They are the policy marker of the hospital, so

they have to be informed and agree for the implementation of a new protocol. Besides,

it will be easier to apply for funding from the hospital if a cost-effective guideline is

presented to them.

4.2 Communication plan

Ingersoll (2005) claimed that effective communication with stakeholders is the

cornerstone of a successful new clinical guideline. Better collaboration of different

parties can be facilitated by effective communication. Hence, the implementation of

the program will be smooth and easier and less conflict will be aroused from

misunderstanding. Hence, the communication plan will be divided into three phases

including initiation, guidance and sustaining.

36

4.2.1 Initiation phase

The initial phase are to identify the staffs concerns about the massage which is

beneficial to labouring women and increases awareness of the proposed treatment in

clinical. The estimated duration of initiation phase is about 20 weeks which including

4 weeks used for guideline and proposal development, 14 weeks used to get the

proposal and budget approval from COS, DOM, and WMs and sending budget plan

and makes grant from the daily expense pool in Ward A for the innovation; one week

is used for formation of an innovation committee, one week is used to convince the

staff to support this innovation. The details are as follows.

The communication proposal and budget plan will be prepared by the proposer in this

phase. The second step is sharing the innovation idea and seeking approval for

funding from the Obstetric Departmental Consultative Committee held by COS,

DOM and WMs monthly. A presentation which focuses on the need and the people

responsible for the innovation, the content of guidelines, the duration of pilot study

and the budget requirements will be made to the COS, DOM and WMs by the

proposer.

After getting the approval, a committee will be formed. The committee includes one

WM act as a leader to promote the innovation; one APN act as a supervisor to

organize the process and 6 senior midwives act as trainers to train other midwives and

act as instructors to labour companions. The proposal and the guideline will be

presented by the WM at the staff meeting held by DOM and WMs monthly. The

midwives will be convinced by the WM to support the innovation by presenting the

current situation and the needs of labour women. The staff will be explained about the

proposal with the massage intervention evidence-based practice (EBP) guidelines,

working flow chart and budget plan. The time spent for the implementation and little

37

impact on workload will be emphasized by the proposer. During the meeting, the

proposer may be required to address concerns and suggestions raised by the midwives

in order to refine the innovation.

Besides, six senior midwives will be identified by the proposer and they will

responsible for instructing other midwives and to execute the innovation. They are the

committee members and have training in massage before and have qualification to

train other midwives. Three one-hour group discussions will be organized and led by

them. Each group includes 10 to 15 midwives. The effectiveness of current

interventions in reducing labour pain will be discussed. Besides, some midwives who

are against this innovation will be convicted so that all midwives will support this

innovation.

The obstetricians, physiotherapists and allied health workers will not directly take part

in this innovation but they also need to be informed by the committee team during the

ward meetings and the flow in recruiting eligible women will also be informed so that

preventing interruption during the intervention.

4.2.2 Facilitating phase

The estimated duration of facilitating phase is about twelve weeks including six senior

midwives in the committee team will be responsible to purchase suitable massage oil

for the massage and act as the trainer to train other midwives.

The midwives training will take place for three weeks. Three identical training

sessions will be provided to midwives who work in different shifts. It is essential to

train the midwives become the trainers to the labour companions in order to enhance

their theoretical knowledge, understand the EBP guidelines and skills practice. In

order to ensure all staff understanding of the innovation, the innovation description

38

and a flow chart will be sent via internal e-mail. The updated progress will also be

sent to midwives to facilitate communication. To keep the EBP guideline up-to-date

and review of the massage intervention annually is needed.

4.2.3 Sustaining phase

The committee focuses on monitoring the midwives acceptance and satisfaction with

the EBP guideline in the sustaining phase. Therefore, a pilot testing will be executed

and discussed. The estimated duration is about 16 weeks including 4 weeks for the

data collection and 12 weeks for the data analysis.

4.3 Pilot study plan

Pilot study is a small-scale pre-study before the implementation of the innovation.

Due to there is no similar guideline before, a trial is essential to perform in order to

ensure the feasibility and evaluate the logistics of the program. Hence, the

administrators will be given confidence to implement the full-scale afterwards. The

objectives of this pilot study are to test the feasibility and acceptability of the program

and assess staff compliance towards the protocol.

4.3.1 Participants

The participants are the eligible women in the labour ward who fulfilled the inclusion

and exclusion criteria. The inclusion criteria includes primiparous women who age

ranged from 16 to 36, have a singleton, with labour companions who attended

antenatal class before and presence during labour, no obstetric, medical complications

or cognitive disability and no infection disease. The exclusion criteria includes

women have spinal injuries and have bone deformity.

39

4.3.2 Procedure

In order to let all the midwives on both AM, PM and night shift experience the

proposed intervention, the implementation will run for 24 hours a day for 4 weeks.

Each of the 42 midwives would have hands-on experience with at least three cases.

Therefore, a total of 126 pilot cases will be recruited.

Triage assessment and recruitment will begin at the labour ward. After recruitment,

informed consent will be signed. According to the guidelines, labour companions will

start 30 minutes massage to the labouring women at the first stage of labour. Each

woman will complete the assessment form of labour pain and anxiety level

(Appendix 5 and 6) after the 30-minute massage and a satisfaction survey with

Chinese and English version respectively (Appendix 13 and 14) will be used to

evaluate their overall satisfaction with their experience of the massage on postnatal

day 1.

Data input and analysis will be carried out in 12 weeks, including eight weeks will be

used to refine the proposed EBP guideline according to the results of the pilot test in

order to tailor-made to the clinical situation.

4.4 Evaluation plan

A detailed plan should be prepared to evaluate the effectiveness of the implementation.

The evaluation takes 24 weeks which includes evaluation of three types of outcomes,

including the pain, anxiety and satisfaction in labouring women, the satisfaction and

acceptance of new guideline of health care providers and the cost of system as

follows.

40

4.4.1 Patient outcome

The primary outcome is pain level of labouring women after massage. The Visual

Analogue Scale (VAS) is used to measure the pain level (Appendix 5). The VAS form

will be given to labouring women after the massage which starts at their cervical

dilation 3 to 4 cm (Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013) so

as to assess the pain level after receiving 30 minutes massage.

The secondary outcomes are the labouring women anxiety and satisfaction levels. The

VAS form (Appendix 6) will be given to labouring women after the massage which

starts at their cervical dilation 3 to 4cm (Mortazavi et al., 2012; Janssen et al., 2012;

Gallo et al., 2013) to assess the anxiety level. They are also asked their satisfaction

during labour by filling a questionnaire on the postnatal day 1. Seven questions are

included in the questionnaire. The women overall satisfaction with massage will be

rated from 1, totally unsatisfied to 5, totally satisfied. If more than four questions

rated for 3 to 5 in the form, that means they are satisfied with the intervention. The

survey will be illustrated in Appendix 13 and 14 respectively.

4.4.2 Health care providers outcome

The health care providers outcome is the job satisfaction and the acceptance of EBP

guidelines of the midwives. This is to evaluate the midwives satisfaction of the

innovation. The staff satisfaction survey (appendix15) and the acceptance survey

(appendix 16) will be used to assess staff satisfaction and acceptance of the EBP

guidelines. Seven questions are included in the questionnaires. The overall

satisfaction and acceptance surveys will be rated from 1, totally unsatisfied to 5,

totally satisfied. If there are above 4 questions rated for 3 to 5 in the forms, that means

41

the staff are satisfied and accept of the EBP guidelines. The questionnaires will be

done at the end of the evaluation period. Afterwards, the committee members will

collect and analyze the questionnaires.

4.4.3 System outcome

The system outcome is the reduction in cost of pharmacological pain relief methods.

The use of pharmacological pain relief methods in the labour ward is reduced

meanwhile the expenditure on the pharmacological pain relief methods will also be

saved in the labour ward. This can be measured by the in-hospital expenditure on the

pharmacological pain relief methods during the three-month evaluation period

compared with last year’s data in the same period.

4.5 Nature of patients to be involved

The participants are the eligible women in the labour ward who fulfilled the inclusion

and exclusion criteria. The inclusion criteria of the participants include primiparous

women who age ranged from 16 to 36, have a singleton, with labour companions

presence during labour, no obstetric, medical complications or cognitive disability and

no infection disease. The exclusion criteria includes women have spinal injuries and

have bone deformity.

4.6 Determining the number of clients

According to Lenth’s (2011) sample size calculator, one-sided sample t-test is used to

estimate the number of sample in order to test for the mean pain scores for a single

group. Polit and Beck (2004) recommended the level of significance is 0.05 and the

power is taken as 80%. The mean VAS score for pain level reduction by 0.5 compared

to those who did not receive massage or more will be regarded as effective. From the

42

reviewed studies, only Karami et al. (2007) provided the standard error (1.02) of VAS

score. The dropout rate is 2% in the reviewed studies (Chang et al., 2002; Karami et

al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). The sample

size should be 29. So, one month will be enough to recruit the planned sample size.

4.7 Data analysis

The Statistical Package for Social Science (SPSS) version 19 will be used to analyze

the collected data. A significance level of 0.05 will be used. For patient outcomes, the

objective is to compare if the mean values of pain and anxiety are lower than those of

the usual care. One-tailed t-test will be used to compare mean values of pain and

anxiety after implementation of intervention respectively against their corresponding

values in the usual care. A one-tailed z-test will be used to test if the proportion of

labouring women rated satisfaction (rated 3 or above in 4 or more questions) of the

EBP guidelines are higher than 60%. For health care provider outcomes, the objective

is to test if the proportion of staff rated satisfaction and acceptance (rated 3 or above

in 4 or more questions) of the EBP guidelines are higher than 60%. A one-tailed z-test

will be used. For the system outcome, the objective is to compare the cost of the

pharmacological pain relief method. The cost of the pharmacological pain relief

method will be calculated and compare with the value before the implementation.

4.8 Basis for an effective change of practice

The reduced pain and anxiety level of labouring in their labour by using 30 minutes

massage will be the foremost important indication of an effective change of practice.

From the reviewed studies, taking the conservative estimation, mean VAS score for

pain level reduction by 0.5 compared to those who did not receive massage or more

43

will be regarded as effective. The mean VAS score for anxiety level reduction by 0.5

or more will be regarded as effective. When 60% of women feel satisfied with

massage in the survey, the satisfaction will be regarded as increased.

The midwives will act as the user level of the innovation. The results are considered

to be positive if the midwives report 3 to 5 in 4 or above questions in the staff

satisfaction and acceptance surveys. When 60% of the midwives report positive in the

surveys, the EBP guideline will be considered acceptable and satisfactory.

Besides, the costs of pharmacological pain relief methods are considered to be

reduced if 30% reductions in using pharmacological pain relief methods (Janssen et

al., 2012).

44

Chapter 5 Conclusion

In view of the prevalence of labour pain, more women will use pharmacological pain

relief methods to relieve pain. Based on the findings of the reviewed literature, a

massage administered by labour companions for labour women not only can relieve

labour pain but also reduce anxiety and increase their satisfaction of labour process. It

is believed that labour women will reduce use of pharmacological pain relief methods

when this evidence-based program is adopted. A well implementation planning and

other considerations such as environment, manpower and cost are the foundation so

that this program can be implemented successfully. Besides, a good communication

plan among different parties is also the major determining issue in the entire program.

From the reviewed literature, the massage program is implemented to labour women

with labour companions, its benefits over the pharmacological pain relief methods in

labour women which is well supported by the reviewed literature ( Chang et al., 2002;


With advance of massage technique, massage will soon become the most common

non-pharmacological pain relief method to labouring women. Therefore, this massage

program should be reviewed and advanced if the massage becomes the main stream of

non-pharmacological pain relief approach.

45

Appendix 1 Search Strategies

Search Items Electronic databases

Pubmed CINAHL

Plus

PsycINFO

Search Date 5/8/2014 5/8/2014 5/8/2014

(1)massage OR massage therapy OR

birth massage

60090 86759 26862

(2)labour obstetric OR parturition 148659 126862 109867

(3)labour pain OR labor pain 138052 148734 12867

(4)anxiety Or anxious OR stress 167926 189672 186796

(1)AND(2) AND ((3)OR (4)) 267 385 309

Limit to RCT OR clinical controlled trial

And Year And full text

150 76 84

Eliminate irrelevant studies after

screening title and abstract

76 23 24

Eliminate duplication with other

databases

34 12 9

Eliminate irrelevant studies after

reviewing full text

5 0 0

Manual search of the reference lists of

selected articles (no addition)

5 0 0

Total 5 0 0

46

Appendix 2 Flow Diagram of the Systematic Search

Records identified

through database

searching

(n= 310)

Additional records

identified through

other sources

(n= 0)

Records after screening title and abstract

(n=123)

Records after duplicate

removed

(n=55)

Full-text articles

assessed for

eligibility

(n=55)

Studies included in

qualitative synthesis

(n=5)

Records excluded

(n= 187)

Full-text articles

excluded

(n=50)

Intervention was not

administered by

labour companions

(n=36)

Intervention was not

started at the first

stage of labour

(n=4)

Outcome measures

were not related to

labour pain or anxiety

(n=10)

47

Appendix 3 Table of Evidence

Bibliographic

Citation,

Study type &

Evidence

level

Patient

Characteristics

Intervention Comparison Outcome measures Effect size

Gallo et

al.,2013

Randomized

Controlled

Trial

++

--Aged 16 to 36

--primigravida

--a singleton

--cephalic

presentation

--equal or more

than 37 weeks of gestation

--spontaneous

onset of labour

--cervical dilation

4-5cm with

appropriate

uterine

contraction

--no use of

pharmacological

pain relief --no medical

problems

--intact

membrane

--literacy

Received a

30-min massage

by a

physiotherapist

during active

phase of labour

(i.e.cervical dilation at 3-4

cm)

(n=23)

Received

routine care

(n=23)

Intensity ,

characteristics,

location of pain and

the time of use

pharmacological

pain relief methods

were assessed after 30 minutes massage

administered in

active phase of

labour

1) The pain intensity

was measured by

visual analogue scale

(0-100mm)

2) The

characteristics of

pain were assessed

by the short-Form

McGill Pain

Questionnaire the

words chosen to

describe the pain

were such as

cramping, arching or

tearing

3)The location of

pain was recorded by using a standard

body diagram

4)The time of use

pharmacological

pain relief methods

1) The pain

intensity

Massage –control:

-20(95%CI -10to

-31)

2)No significant

difference in the

characteristics of

pain in two groups

3)The location of pain were the same

in suprapubic and

lumbar region in

two groups

4)The time of use

pharmacological

pain relief methods

Massage-control:

0.7 (95%CI -0.1

to1.5)

48

Bibliographic Citation,

Study type &

Evidence

level

Patient characteristics


Mortazavi et

al., 2012

Clinical

controlled

trial

+

--Age between

16 and 36

--normal

pregnancy

without any

complications

--gestation age

between 37 and 42 weeks

--cervical

dilatation less

or equal to

4cm

A 30-min

massage done

by labour

companions at

cervical dilation

at 3-4 cm and in

3 phases of

labour (n=40)

Labour

companions

present in 3

phases of

labour

(n=40)

Received

routine care

(n=40)

The length of active

phase in labour, the

intensity of pain, the

level of anxiety and

satisfaction were

assessed after 30

minutes of massage

in 3phases of labour.

1)The length of

active phase in

labour

2)The intensity of

pain was measured

by a numeric analog

scale of self -reported

present pain intensity

(PPI) scale as

follows: 0, no pain;1,mild pain;2,

moderate pain; 3,

distress; 4, severe

pain and 5,

intolerable pain

3)The level of

anxiety was measures

with the standard

visual analog

scale(VAS) which consists 10-cm

horizontal line define

no anxiety at the left

and worst anxiety at

the right

4)Satisfaction with

labour

companionsperforme

d massage was

measured by the

standard visual analog scale (VAS)

which consists of 1

10-cm horizontal

line , the high values

showed increase in

the level of

satisfaction

1)Mean active phase

length:

Massage group :

2.6h(SD=0.95h)

Attendant group:

5.7 h(SD=1.89h)

Control group:

7.5h( SD=1.87h) The massage had a

shorter duration of

active phase in

labour (p<0.001)

2) Massage group

had significantly

lowest pain level

among three groups

in the 3 phases of 1st

stage of labour : 7.83

(p<0.005)

3)Massage group

had significantly

lowest level of

anxiety among 3

groups in 3 phases

of 1st stage of

labour : 6.5

(p<0.005)

4)Satisfaction level

was significantly

higher in massage group in 3 phases of

1st stage of labour :

7.65 (p<0.001)

49

Bibliographic

Citation ,

Study type &

Evidence level

Patient

Characteristics

Intervention

Comparison

Outcome measures

Effect size

Janssen et al.,

2012

Randomized

controlled trial

++

--Null parity

--Singleton

--Cephalic

presentation

--37-41 weeks

of gestation

--Age

between18 and

35

--Spontaneous

onset of labour

--Ability to speak and read

English

Massage started

at 3-4 cm

cervical dilation

and administered

up to 5 hours by

a registered

massage therapist

(n=37)

Received

routine care

(n=40)

Cervical dilation at

the time of

administration of

epidural analgesic,

the pain intensity in

3 phases of labour

and the length of

first and second

stage of labour

were assessed after

5 hours of massage

administration. 1)Cervical dilation

at the time of

administration of

epidural analgesic

2)The pain intensity

in 3 phases of

labour was

measured by The

Short form McGill

Pain Questionnaire,

0=none, 1=mild,

2=moderate and

3=severe pain

3)The length of

first and second stage of labour

1)Cervical dilation at

the time of

administration of

epidural analgesic:

Massage group5.9

cm(95% CI 5.2-6.7)

Control group4.9

cm(95%CI 4.2-5.8)

Epidural analgesic was

significant requested

earlier in control group (p<0.005).

2)The pain intensity in 3

phases of labour:

During latent phase:

Massage group=3.7

Control group=6.9

During active phase:

Massage group=5.4

Control group=8.3

During transitional phase:

Massage group=4.4

Control group=7.3

Massage group had

significantly less pain in

3phases of labour

(P<0.005).

3) The length of lst

stage of

labour(min):

Massage group=897.4

Control group=788.6(P

<0.028)

The length of 2nd stage

of labour (min):

Massage group=136

Control group=125 (P <0.036)

There were statistically

significant differences in

the length of labour.

50

Bibliographic Citation,Study

type &

Evidence level

Patient characteristics


Karami et al.,

2007

Clinical

controlled trial

－

--Primiparous

--Age at25 to

35

--Singleton

--38to 42

weeks of

gestation

Massage stated

at cervical

dilation at 8cm

of first stage of

labour and

administered

for 30 minutes (n=30)

Received

routine care

(n=30)

The severity of

pain and the

duration of 1st and

2nd stage of labour

were assessed after

administration of

massage.

1) The severity of

pain in the first

stage of labour was

measured by visual

analogue scale

(VAS) which is a

10-cm line, the

right and left

extremes of the line

were noted as pain free and the most

severe pain.

2) The duration of

1st and 2nd stage of

labour

1)The severity of pain

in the first stage of

labour

Mean of labour pain

scores:

Massage group: 7.22

(SD=0.83) Control

group:7.84(SD=1.02)

Massage group had a

significantly less pain in

the first stage of labour

(P<0.004).

2)The duration of 1st

stage of labour:

Massage

group=264.16mins Control

group=362.5min

Massage group has

significantly shorter

duration of 1st stage of

labour (P<0.001).

The duration of 2nd

stage of labour:

Massage

group=37.16min

Control group=30.50 min

Nosignificant difference

in two groups

In the 2nd stage of

labour (p=0.157).

51

Bibliographic

Citation,

Study type &

Evidence

level

Patient

characteristics


Chang et

al.,2002

Randomized

controlled

trial

++

--aged 18 to 36

--between 37and

42 weeks of

gestation

--labour

companions

presented during

labour

--estimated

cervical dilatation less or equal

to4cm

A 30-min

massage

started at

cervical

dilation at

3-4 cm and

performed by

labour

companions

at 3 phases of 1st stage of

labour

(n=30)

A routine care

and 30-min of

researcher’s

attendance

with

conversation

at 3 phases of

1st stage of

labour

(n=30)

The intensity of

pain, the anxiety

level, satisfaction

of laboring women

and satisfaction of

labour companions

were assessed after

administered 30

minutes of

massage.

1)The intensity of

pain at 3 phases of

1st stage of labour

was measured by

the self –reported

present

intensity(PPI)

scale, a measure of

the overall

intensity on a scale of 0-5: 0 represents

no pain;1,mild; 2

discomforting;

3,distressing; 4

horrible;

5excruciating pain.

2) The anxiety

level at 3 phases of

1st stage of labour

was measures by

the visual analogue

scale which

consists of 1 10-cm

horizontal line with

the descriptors ‘no

anxiety’ at the left

and ‘worst possible

anxiety’ at the

right.

3) Satisfaction of

support from

partners

4)Satisfaction of

partners being as

labour companions

1)The intensity of

pain at 3 phases of 1st

stage of labour:

Massage-control

Latent phase

-0.57 (p=0.000)

Active phase

-0.43 (p=0.002)

Transitional phase

-0.70 (p=0.00) Significantly lower

PPI scores in the

massage group at 3

phases of 1st stage of

labour.

2)The anxiety level at

3 phases of 1st stage

of labour:

Massage –control

Latent phase -16.27

(p=0.040) Active phase -8.93

(p=0.0144)

Transitional

phase-4.50

(p=0.0355)Statically

significant of lower

anxiety in massage

group in 3 phases of

1st stage of labour

3)Satisfaction of

support from partners d=0.57, (95% CI of

d=0.09-1.04 ,

p=0.019)

Significantly increase

in satisfaction of

support from

labouring women.

4)Satisfaction of

support from partner

being as labour

companions: d=0.70, 95% CI of

d=0.30-1.10, p=0.001). Significantly

increase in

satisfaction of partners being as

labour companions.

52

Appendix 4 SIGN-critical appraisal checklist

Gallo et al

2013

Janssen et al

2012

Mortazavi et al

2012

Karami et al

2007

Chang et al

2002

Appropriate &

clearly focused

question

Well

covered

Well

covered

Well covered Well

covered

Well

covered

Randomization

method

Well

covered

Well

covered

Not applicable Not

applicable

Well

covered

Concealment

method

Well

covered

Well

covered

Not applicable Not

applicable

Well

covered

Blinding Well

covered

Adequately

addressed

Not applicable Not

applicable

Adequately

addressed

Similar at the

start of the trial

Well

covered

Well

covered

Adequately

covered

Adequately

covered

Well

Covered

Only

difference

between

groups is the

treatment

under

investigation

Well

covered

Well

covered

Well

covered

Well

covered

Well

covered

Standard

measurement

Well

covered

Well

covered

Adequately

addressed

Adequately

addressed

Well

covered

Dropout rate Well

covered

(2%)

Well

Covered

(2%)

Adequately

addressed

(2%)

Adequately

Addressed

(2%)

Well

covered

(2%)

Intention to

treat

Adequately

addressed

Adequately

addressed

Poorly

addressed

Not

addressed

Adequately

addressed

Carried and

compare at

different sites

Not

applicable

Not

applicable

Not applicable Not

applicable

Not

applicable

Rating ++ ++ + --

(Due to the

small

sample

size )

++

53

Appendix 5 VAS for pain level

INSTRUCTIONS:

The level of pain is described in a 10-cm linear line from the left to the right. The left

is ‘0’ (the least pain) and the right is ‘10’ ( the most pain ). Choose a number below

that indicates how you feel the pain right now, that is, at this moment. There is no

right or wrong answer.

0 1 2 3 4 5 6 7 8 9 10

Source:

VAS: Kahl, C., & Cleland, J. A. (2005). Visual analogue scale, numeric pain rating

scale and the McGill pain questionnaire: An overview of psychometric properties.

Physical Therapy Reviews, 10, 123-128.

Please stick patient’s gum

label here

Official use:

At the cervical dilation at 3 to 4cm

Cubicle □ Delivery room □

Massage therapy

Given □ N/A □

54

Appendix 6 VAS for anxiety level

Official use:

INSTRUCTION

The level of anxiety is described in a 10-cm linear line from the left to the right. From

the left ‘0’ indicates no anxiety, from the right ‘10’ indicates the most anxiety. Choose

and circle a number which indicates how anxiety you fell right now.

0 1 2 3 4 5 6 7 8 9 10

Source:

VAS: Kahl, C., & Cleland, J. A. (2005). Visual analogue scale, numeric pain rating

scale and the McGill pain questionnaire: An overview of psychometric properties.

Physical Therapy Reviews, 10, 123-128.

Please stick patient’s gum label

here

Official use:

At the cervical dilation at 3 to 4 cm

Cubicle □ Delivery room □

Massage therapy

Given □ N/A □

55

Appendix 7 Set up cost for massage therapy

Expense Quantity Amount (HKD)

Training sessions for

midwives

32 midwives in Ward A

1 hour per midwife in

training session

Estimated mean salary of

a midwife $33000

Hourly salary:

$33000 ÷ 44( hours

/week) ÷4

(week/month)= $187.5

32 hours

$6000

The salary of a

physiotherapist as a

demonstrator in 3 hours

demonstration

1 physiotherapist as a

demonstrator in 3 hours

demonstration

Estimated mean salary of

a physiotherapist

$22000

Hourly salary:

$22000 ÷ 44

(hours/week) ÷ 4

(week/ month) = $125

3 hours

$375

Photocopies

Instruction sheet ( 1 for

each midwife)

Survey (for midwives)

$0.3 X 42

$0.3X 42

$25.2

Total setup cost

$ 6400.2

56

Appendix 8 Estimated recurrent costs for massage therapy

Recurrent cost per month

Expense Quantity Amount(HKD)

Photocopies

Survey ( For client) ( $0.6 per set)

VAS form for labour pain level

( $0.3 )

VAS form for anxiety level ($0.3)

383 sets

383 sets

383 sets

$459.6

Stationary

Pen

Readily

available

Computer

For data input and analysis

Readily

available

Manpower

Supervisor for data collection, input

and analysis

5-day work , 8 hours per day

Hourly salary

$33000 ÷ 44( hours /week) ÷4


40 hours

$7500

Manpower

Midwives for instructing the labour

attendances to perform massage

5 minutes instruction for each case

383 cases per month

Hourly salary

$33000 ÷ 44( hours /week) ÷4


31.9 hours

$5984.3

57

Appendix8 (Continue)

Recurrent cost per month

Training session for new staff per month

1 new midwife in Ward A

1 hour for the midwife in training

session

Hourly salary:

$33000 ÷ 44 (hours/week) ÷4

(week/month) =$187.5

The trained senior midwife as the trainer

1 hour for the training

Hourly salary:

$33000 ÷ 44 (hours/week) ÷4

(week/month) =$187.5

1 hour

1 hour

$ 375

Training sessions for labour attendants per

month

4 training sessions in 1 month

2-hour training session in each

antenatal class

3 midwives in each antenatal class

Hourly salary

$33000 ÷ 44( hours /week) ÷4


4 x 2 x3

$4500

Total recurrent cost

$ 18818.9

58

Appendix 9 Estimated savings for massage therapy

Monthly delivery cases in Ward A

680

Around 86% women who are primiparous

584

Around 82% primiparous women with labour companions

willing to perform massage therapy

(Assuming physiotherapists are not available for massage)

383

Around 30% primiparous women decrease to use

pharmacological pain relief methods

115

115 Primiparous women with massage therapy reduce 1

cylinder of Entonox usage

115(primiparous women with massage therapy) x $600 (1

cylinder of Entonox)

$69000

383 (primiparous women with massage therapy) × 30 min per

case

The total man-power saved to administer massage to

labouring women among physiotherapists is 11490 minutes

monthly

Hourly salary :

$22000 ÷ 44 (hours/ week )÷ 4( weeks /month)= $125

Salary saved for shortening of labouring time

(11490÷ 60) × $125

$23937.5

Estimated benefit for massage therapy per month:

$(69000 + 23937.5)

$92937.5

59

Appendix 10

An evidence based protocol on massage therapy

administered by labour companions to labouring women Date released: January 2015

Version: Version 1

Protocol prepared by: Tse Lai Fan, Registered Midwife and Nurse

1. Background

Pain in labour is inevitable. As the labour proceeds to advance stages, the labour pain

and anxiety also increased (Chang et al., 2002). Pharmacological and

non-pharmacological pain relief methods are provided to labouring women.

Pharmacological pain relief methods such as injection of Pethidine or inhalation of

Entonox not only cause adverse effects on maternal such as drowsiness and low blood

pressure, but also on neonatal such as respiratory depression (Mccaffery & Beebe,

1989; Mobily, et al., 1994). Therefore, the non-pharmacological pain relief methods

such as breathing exercises, birth ball, music therapy and massage therapy become

more common in labour pain relief.

Anxiety is a co-existing factor with labour pain when women in their labour.

Anxiety would cause physical changes like elevated blood pressure and palpitation

(Alan, 2000). Therefore, anxiety of labouring women is not only affect their physical

but also psychological status such as psychological satisfaction. Besides, anxiety also

interferes with the duration of labour and induces a longer duration of labour pain

(Alan, 2000).

60

Labouring women psychological satisfaction is correlated to the presence of labour

companions. The labour companions support during labour is useful when the labour

companions are able to help the labouring women to meet their needs during labour

such as relieving labour pain or anxiety (Kenian & Hobfall, 1989).

Therefore, massage therapy as a non-pharmacological pain relief method provided by

labour companions not only relieve pain or anxiety but also increases psychological

satisfaction of labouring women and a positive relationship between labouring women

and labour companions would be promoted (Chang et al., 2002). Besides, massage

therapy showed no adverse effects on both maternal and neonatal (Chang et al., 2002;


Massage therapy is a set of specialized hand movements with different sequences to

provide a soothing pressure on skin of different parts of body (Chang et al., 2002;

Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). It

has been shown to be safe and effective in reducing labour pain or anxiety in

laboruing women (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012;

Janssen et al.m, 2012; Gallo et al., 2013).

2. Objectives

The protocol aims at providing evidence based-guidance for midwives on the

management pain or anxiety in labouring women using massage therapy administered

by labour companions in the obstetric ward of a local hospital in order to:

i. Select appropriate women with labour companions to receive massage therapy,

61

ii. Standardize the management of labouring women with massage therapy

administered by labour companions,

iii. Serve as a quick reference for the use of massage therapy in labouring women

3. Target population

Primiparous labouring women administered massage therapy by labour companions

during their labour.

Inclusion criteria:

Aged 18 to 36

Women have a singleton

Women have labour companions who attended in antenatal class and present

during labour

No obstetric or medical complications

No Cognitive disability

No infection disease such as tuberculosis

Exclusion criteria:

Women have spinal injuries

Women have bone deformity such as scoliosis, kyphosis

62

4. Keys to level of evidence and grade of recommendation

In this evidence-based practice protocol on massage therapy administered by labour

companions to labouring women during labour, the system developed by the Scottish

Intercollegiate Guidelines Network (SIGN) (SIGN, 2012) was used to indicate the

level of evidence and grade of recommendation (Appendix 11) of each evidence

based recommendation.

5. Evidence- based recommendations

5.1 Recommendation 1

Primiparous women who have singleton and at gestation weeks 35 to 37 should attend

the antenatal class with at least 2 hours massage therapy training with their labour

companions. (Grade of recommendation: A)

Evidence:

The antenatal class provides massage therapy training under the midwives supervision

can let the labour companions and women are more familiar with massage therapy

and they can practice by their own after the training (Chang et al., 2002; Karami et al.,

2007; Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). (1++, 1－, 1+,

1++, 1++)


Trained midwives can teach labour companions to perform massage therapy. (Grade

of recommendation: A)

Evidence:

Trained midwives have qualifications to teach the labour companions to perform

massage therapy (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012).

63

(1++, 1－, 1+)


The general condition of labouring women and their fetal condition will be assessed

before providing the massage therapy. (Grade of recommendation: A)

i. Women shall be assessed by an obstetrician to exclude any evidence of

maternal or fetal complications.

ii. Midwives shall confirm that the labouring women fulfill all the

eligibility criteria.

Evidence:

In order to ensure the safety of labouring and fetus, the five reviewed literatures

suggested that midwives should assess the maternal and fetal condition before the

labour companions applying massage therapy (Chang et al., 2002; Karami et al., 2007;

Mortazavi et al., 2012; Janssen et al., 2012; Gallo et al., 2013). (1++, 1－, 1+, 1++,

1++)


The labouring women should have labour companions such as husbands and relatives

to perform massage to them. If no labour companions present in the labour,

physiotherapists or registered massage therapist can perform massage therapy to them.

(Grade of recommendation: A)

Evidence:

Mostly labouring women have husbands to perform massage therapy to them during

labour. (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012). (1++, 1－,

1+) If husbands are not presented in the labour, relative followed by physiotherapists

64

(Gallo et al., 2013) (1++) or registered massage therapists (Janssen et al., 2012) (1++)

can perform massage therapy to the labouring women. All five reviewed studies

suggested that labouring women have labour companions not only provide

psychological support but also can perform massage therapy to relieve their pain and

anxiety. The pain and anxiety level of labouring women were significantly reduced

after receiving massage therapy (Chang et al., 2002; Karami et al., 2007; Mortazavi et

al., 2012; Janssen et al., 2012; Gallo et al., 2013). ( 1++, 1－, 1+, 1++, 1++)


The labouring women can self-select different types of massage (e.g. Swedish

massage). (Grade of recommendation: A)

Evidence:

There are different types of massage (e.g. Swedish massage ) could be administered to

women in order to relieve their labour pain or anxiety (Karami et al., 2007; Mortazavi

et al., 2012; Janssen et al., 2012). (1－,1++, 1++ )


The labouring women can self-select different massage positions (e.g. supine, side

lying or prone position). (Grade of recommendation: A)

Evidence:

The labouring women are able to self -select massage position (e.g. supine, side lying

or prone position) to promote their comfort which show significant pain and anxiety

reduction (Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et

al., 2012; Gallo et al., 2013). (1++, 1－, 1+, 1++, 1++)

65


There are different points of body can be administered massage therapy (e.g. hands,

shoulders, lower back or buttock). (Grade of recommendation: A)

Evidence:

There are different points of body can be administered massage therapy such as hands,

shoulders, lower back (Chang et al., 2002; Mortazavi et al., 2012) (1++, 1+) or

buttock (Janssen et al., 2012) (1++) which show significant pain reduction.


Duration of massage therapy should be 30 minutes. (Grade of recommendation: A)

Evidence:

There was the common duration of massage therapy described in four reviewed

literatures which showed significant reduction in labour pain (Chang et al., 2002;

Karami et al., 2007; Mortazavi et al., 2012; Gallo et al., 2013). (1++, 1－, 1+, 1++)


Massage therapy should be started to administer at cervical dilation at 3 to 4 cm at the

first or second stage of labour. (Grade of recommendation: A)

Evidence:

Massage therapy started to administer by labour companions during cervical dilation

at 3 to 4 cm at the first stage of labour or at the second stage of labour can

significantly reduce labour pain or anxiety of target labouring women in their labour

(Chang et al., 2002; Karami et al., 2007; Mortazavi et al., 2012; Janssen et al., 2012;

Gallo et al., 2013). (1++, 1－, 1+, 1++, 1++)

66

The length of first or second stage of labouring women is also shorten after receving

massage therapy (Karami et al., 2007; Mortazavi et al., 2012). ( 1－, 1+)

6 Recommendation 10

The Visual Analogue Scale (VAS) is used to measure the labouring women pain level

in the Ward A after the massage therapy. (Grade of recommendation: A)

Evidence:

Three out of five relevant studies performed VAS as the measuring tool in evaluating

the pain level. These studies demonstrated a significant decrease in pain level after the

massage therapy (Chang et al., 2002; Karami et al., 2007; Gallo et al., 2013). (1++, 1

－,1++)


The Visual Analogue Scale (VAS) is used to measure the labouring women anxiety

level in the Ward A after the massage therapy. (Grade of recommendation: A)

Evidence:

Two out of five relevant studies performed VAS as the measuring tool in evaluating

the anxiety level. These two studies demonstrated a significant decrease in anxiety

level after the labour companions administered massage therapy (Chang et al., 2002;

Mortazavi et al., 2012). (1++, 1+)

7 References

Alan, E. (2002). Encyclopedia of Psychology: 8 Volume Set. America: American

Psychology Association and Oxford University Press.

67

Chang, M., Wang, S., & Chen, C. (2002). Effects of massage on pain and anxiety

during labour: a randomized controlled trial in Taiwan. Journal of advanced Nursing,

38 (1), 68-73.

Gallo, R. B., Santana, L.S., Ferreira, C. H., Marcolin, A. C., PoliNeto, O. B., Duarte,

D., & Guintana, S. M. (2013). Massage reduced severity of pain during labour: a

randomized trial. Journal of Physiotherapy, 59, 109-116.

Janssen, P., Shroff, F., & Jaspar, P. (2012). Massage therapy and labour outcomes: a

randomized controlled trial. International Journal of Therapeutic and Bodywork, 5(4),

15-20.

Karami N. K., Safarzedeh, A., & Fathizadeh, N. (2007). Effect of massage therapy on

severity of pain and outcomes of labour in primipara. Iranian Journal of Nursing and

Midwifery Research, 12(1), 6-9.

Keinan, G., & Hobfall, S. E. (1989). Distress, dependency, and social support: who

benefits from father’s presence in delivery. Journal of Social and Clinical Psychology,

8, 32-44.

McCaffery, M., & Beebe, A. (1989). Pain: Clinical Manual for Nursing Practice. St

Louis: Mosby.

Mobily, P. R., Herr, H. A., & Nicholson, A. C. (1984). Validation of cutaneous

stimulation intervention for pain management. International Journal of Nursing

68

Studies, 31, 533-544.

Mortazavi, S. H., Khaki, S., Moradi, R., Heidari, K., & Rahimparvar, S. F. (2012).

Effect of massage therapy and presence of attendant on pain, anxiety and satisfaction

during labour. Maternal-Fetal Medicine, 286, 19-23.

69

Appendix 11

Key to evidence statements and grades of recommendation (SIGN 2012)

Levels of evidence

1++ High quality meta-analysis, systematic reviews of RCTs, or RCTs with a

very low risk of bias

1+ Well conducted meta-analyses, systematic reviews, or RCTs with a low

risk of bias

1- Meta analyses, systematic reviews, or RCTs with a high risk of bias

2++ High quality systematic reviews of case control or cohort studies

High quality case control or cohort studies with a very low risk of

confounding or bias and a high probability that the relationship is causal

2+ Well-conducted case control or cohort studies with a low risk of

confounding or bias and a moderate probability that the relationship is

causal

2- Case control or cohort studies with a high risk of confounding or bias and

a significant risk that the relationship is not causal

3 Non-analytic studies, e.g. case report, case series

4 Expert opinion

Grades of recommendation

A At least one meta -analysis, systematic review, or RCT rated as 1++, and

directly applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly

applicable to the target population, and demonstrating overall consistency

of results

B A body of evidence including studies rated as 2++, directly applicable to

the target population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C A body of evidence including studies rated as 2+, directly applicable to the

target population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D Evidence level3or4; or

Extrapolated evidence from studies rated as 2+

70

Appendix 12

Estimated schedule for implementation and evaluation

Phase Description Duration

Initiation phase Guideline and proposal development

Proposal and budget approval

Send proposal for COS , DOM and WM

for approval

Send budget plan and make grant from

the daily expense pool in Ward A for the

innovation

4 weeks

14 weeks

Formation of the committee

1 WM : as a leader to promote the

innovation

1 APN: as a supervisor for organize the

process

6 senior midwives: as trainer to train

other midwives and as instructors to

labour companions

1 week

Three One-hour group discussions

Organized and led by 6 senior midwives

Discuss the effectiveness of current

intervention

Convict all midwives support the

innovation

1 week

Facilitating phase Purchase of the massage oil

3 midwives : select and purchase the

suitable massage oil

3 weeks

9 weeks

Training to the Ward A staff

Three 1-hour identical training session

provide for midwives who work in

different shifts

The intervention flow in Ward A

71

Sustaining phase

Pilot study

Implementation of the pilot program

Execute within12 weeks, 24 hours a day

The pain level and anxiety level forms

and satisfaction survey given to the

selected labouring women

Satisfaction survey for Staff

Data input and analysis

Refine the proposed EBP guidelines

4weeks

12 weeks

Evaluation The pain ,anxiety and satisfaction level

in labouring women

The satisfaction and acceptance level of

staff

The system outcome

24 weeks

72

Appendix 13

Labouring women satisfaction survey on massage therapy by labour companions in

Ward A. (English version)

1. Do you like administering massage therapy during labour?

(1= totally disagree, 5= totally agree)

1 □ 2 □ 3 □ 4 □ 5□

2. Do you think the duration of the massage therapy is suitable?


1 □ 2 □ 3 □ 4 □ 5 □

3. Do you satisfy with the massage position?

(1=totally disagree, 5=totally agree)

1 □ 2 □ 3 □ 4 □ 5 □

4. Do you think the massage therapy administered by labour companions can help you

reduce labour pain or anxiety during labour?

(1=totally disagree, 5=totally agree)

1 □ 2 □ 3 □ 4 □ 5 □

5. Do you like the massage therapy as a non-pharmacological pain relief method?

(1=totally dislike, 5=totally like)

1 □ 2 □ 3 □ 4 □ 5 □

6 .Overall, I feel satisfy with the massage therapy?

(1= totally unsatisfied, 5= totally satisfy)

1 □ 2 □ 3 □ 4 □ 5 □

7. Will you choose massage therapy as a non-pharmacological pain relief method in

the future pregnancy?


1 □ 2 □ 3 □ 4 □ 5 □

73

Appendix 14

產房孕婦接受按摩治療滿意程度問卷調查

1. 你喜歡在生產中進行按摩治療？

(1=非常不同意, 5=非常同意)

1□ 2□ 3 □ 4 □ 5 □

2. 你認為按摩治療的時間合適嗎？


1 □ 2 □ 3 □ 4 □ 5 □

3. 你認為按摩治療能夠減低生產前的痛楚嗎？


1 □ 2 □ 3 □ 4 □ 5 □

4. 你喜歡陪產者為你進行的按摩嗎？


1 □ 2 □ 3 □ 4 □ 5 □

5. 你喜歡按摩作為一個止痛方法嗎？

(1=非常不喜歡, 5=非常喜歡)

1 □ 2 □ 3 □ 4 □ 5 □

6. 整體來說，我對按摩治療滿意程度


1 □ 2 □ 3 □ 4 □ 5 □

7. 你將來生產會再選擇按摩治療作為止痛方法嗎？


1 □ 2 □ 3 □ 4 □ 5 □

74

Appendix 15

Staff satisfaction survey on massage therapy which reduces either labour pain or

anxiety of laboring women in Ward A.


1. The objectives includes reduce labour pain and anxiety and increase satisfaction of

labouring women in this innovation are achieved.

1 □ 2 □ 3 □ 4 □ 5 □

2. The duration of the massage therapy is suitable.

1 □ 2 □ 3 □ 4 □ 5 □

3. The extra workload for guiding the labour companions to administer massage

therapy for laboring women is affordable.

1□ 2□ 3□ 4□ 5□

4. I think massage therapy is useful to reduce labour pain of labouring women in

Ward A.

1□ 2□ 3□ 4□ 5□

5. I think massage therapy is useful to reduce anxiety in laboring women in Ward A.

1□ 2□ 3□ 4□ 5□

6. I feel confident in instructing the labour companions to administer massage therapy.

1□ 2□ 3□ 4□ 5□

7. I believe the quality of care will be enhanced by massage therapy.

1□ 2□ 3□ 4□ 5□

75

Appendix 16

Staff survey on acceptance of EBP guidelines in Ward A. (1= totally disagree, 5=

totally agree)

1. The EBP guideline for massage therapy is user friendly.

1 □ 2 □ 3 □ 4 □ 5 □

2. The EBP guideline for massage therapy is easy.

1 □ 2 □ 3 □ 4 □ 5 □

3. The flow of using massage therapy in labouring women is easy to follow.

1 □ 2 □ 3 □ 4 □ 5 □

4. I have confidence in using massage therapy which followed by the EBP guideline.

1 □ 2 □ 3 □ 4 □ 5 □

5. The EBP guideline is useful when instructing the labour companions to perform

massage therapy.

1 □ 2 □ 3 □ 4 □ 5 □

6. The EBP guideline should be promoted in other obstetric wards such as antenatal

ward.

1 □ 2 □ 3 □ 4 □ 5 □

7. Massage therapy should be promoted to other obstetric wards in HK.

1□ 2□ 3□ 4□ 5□

76

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