Women and Birth 29 (2016) 430435

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Women and Birth

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ORIGINAL RESEARCH QUANTITATIVE

Randomised controlled trial using smartphone website vs leaet

to support antenatal perineal massage practice for pregnant women
Shoko Takeuchi a,*, Shigeko Horiuchi b,c
a
Yokohama City University, Kanagawa, Japan
b
St Lukes International University, Tokyo, Japan
c
St Lukes Birth Clinic, Tokyo, Japan

A R T I C L E I N F O A B S T R A C T

Article history: Background: In Japan, the rate of pregnant women who practice antenatal perineal massage was only 15.1%.
Received 15 August 2015 Aim: The aim of this study was to develop and evaluate a smartphone website and a leaet to support
Received in revised form 14 January 2016 antenatal perineal massage practice for primiparous women.
Accepted 27 January 2016
Methods: In a randomised control trial, 161 primiparous women were randomly assigned to a
smartphone website group (n = 81) or a leaet group (n = 80). Data analysis were by per protocol analysis
Keywords: and intention to treat analysis.
Perineum
Findings: Of the 161 women participants, 47 in the smartphone website group and 49 in the leaet group
Massage
Pregnancy
completed all questionnaires. Primary outcome was continuance rate (three times a week over a three
Instruction week period) of antenatal perineal massage practice. The rates by a per protocol analysis were 51.1% in
Randomised controlled trial the smartphone website group and 51.0% in the leaet group, respectively. There was no signicant
difference between the groups. Moreover, the rates by an intention to treat analysis were 29.6% in the
smartphone website group and 31.3% in the leaet group, respectively. There was also no signicant
difference between the groups.
There were no signicant differences in the evaluation of perineal massage, childbirth self-efcacy,
satisfaction with efforts towards childbirth, and perineal outcomes following childbirth which were
measured as secondary outcomes between the groups.
Conclusion: There was no signicant difference in continuance rate of antenatal perineal massage
practice between those using a smartphone website and those with a leaet, however, the rate was
better than no instructions.
2016 The Authors. Published by Elsevier Ltd on behalf of Australian College of Midwives. This is an open
access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Summary of relevance:

Issue half of Japanese medical facilities did not educate about ante-
natal massage technique.
The rate of antenatal perineal massage practice is only 15.1% in
Japan. What this paper adds

What is already known

We developed two educational materials (a smartphone website
and a leaet) to support antenatal perineal massage practice.
The episiotomy rate in Japan is higher than other developed
countries and Asian ethnicity was associated with a risk of
severe perineal trauma. Antenatal perineal massage for primip-
arous women was associated with a reduction in the incidence
1. Introduction
of perineal trauma requiring suturing and episiotomy. However,
1.1. Background
* Corresponding author at: Yokohama City University, 3-9 Fukuura, Kanazawa-
ku, Yokohama, Kanagawa, Japan. Tel.: +81 45 787 2548. Perineal trauma following childbirth has not only short-term
E-mail address: shoko@yokohama-cu.ac.jp (S. Takeuchi). effects such as perineal pain but also long-term effects such as

http://dx.doi.org/10.1016/j.wombi.2016.01.010
1871-5192/ 2016 The Authors. Published by Elsevier Ltd on behalf of Australian College of Midwives. This is an open access article under the CC BY-NC-ND license (http://
creativecommons.org/licenses/by-nc-nd/4.0/).
 S. Takeuchi, S. Horiuchi / Women and Birth 29 (2016) 430435 431

coital pain or hesitation for the next delivery.1,2 Episiotomiesre- 2. Methods

present one type of trauma. Various guidelines3,4 recommend
restrictive episiotomies as opposed to routine; however, the 2.1. Study design and participants
episiotomy rate in Japan is 30100% for primiparous and 1070%
for multiparous pregnant women indicating that at some A randomised controlled trial was conducted at three hospitals
hospitals episiotomies are routine for primiparous women.5 On and two clinics in Tokyo, Japan. Participants were recruited who
the other hand, the rates of episiotomies in some comparable corresponded to all the following at 3033 weeks of gestation: (1)
countries are 2728% in the USA, 331% in Canada, and 9.920.9% progress of pregnancy was normal; (2) primiparous; (3) could read
in Australia.6 The episiotomy rate in Japan is higher than those and write Japanese and (4) had a smartphone. Questionnaires were
countries because of less mobility during labour or medical distributed and collected over an eight-month period from April
facilities policy. Moreover Asian ethnicity was associated with a 2014 to November 2014. Participants completed questionnaires
risk of severe perineal trauma such as third-degree or fourth before starting perineal massage and after giving birth. The
degree lacerations.7 Institutional Review Board at St. Lukes International University,
Antenatal perineal massage is a preventive method for Tokyo, Japan approved this study (No. 14-001).
reducing perineal trauma of childbirth. A systematic review of
antenatal perineal massage reported that antenatal perineal 2.2. Study outcomes
massage for primiparous women was associated with a
reduction in the incidence of trauma requiring suturing and Primary outcome was continuance rate of antenatal perineal
episiotomy.8 In Japan, a previous study also found that pregnant massage practice. This study regarded continuance as the practice
women who practiced perineal massage felt pain or were of antenatal perineal massage that began about three weeks before
uncomfortable after starting the massage. However, as they labour, and was conducted three times a week.
continued the massage, their pain eased and they felt the Secondary outcomes were; (1) evaluation of perineal massage,
softening of their perineum.9 However, the rate of antenatal (2) satisfaction with efforts towards childbirth, (3) childbirth
perineal massage practice was only 15.1% in Japan.10 An self-efcacy and (4) the degree of perineal trauma following
empirical investigation for identifying factors impeding preg- childbirth.
nant womens massage practice reported that these factors
included: resistance to touching their perineum, lack of 2.3. Sample size
knowledge and some difculty practicing the massage tech-
nique.11 In addition, it was found that women who continued to Sample size in this study was calculated based on a previous
practice perineal massage felt signicantly more positive effects study that veried the effect of web-based education.19 In that
on preparation for childbirth and effects on childbirth when study, pregnant women in the intervention group received web-
compared to those who stopped practicing the massage. The based education about breastfeeding and those in the control
results suggested that midwives needed to support pregnant group received education as usual. As a result, the continuance rate
women to continue the massage practice. of breastfeeding at six weeks postpartum was 80% in the
Midwives educational efforts have traditionally been face-to- intervention group and 58.3% in the control group. Therefore,
face. However, with advances in technology as was noted earlier based on this difference, the sample size was calculated as
the internet is being used as an educational tool and the positive 53 women in each group to detect a difference between groups at a
effects of web-based education are reported around the world.12 5% level of signicance with 80% power. Considering the dropout
37
Moreover, in Japan, the internet user rate of those ages 1349 rate to be 20% from previous studies, the sample size needed was
is over 95% and the smartphone ownership rate has increased 67 women in each group.
rapidly, rising from 9.7% in 2010 to 64.2% in 2014.38 Dennison
et al.39 reported that young healthy adults had some interest 2.4. Randomisation
in smartphone application for supporting health-related behav-
iour change. Midwives educational efforts might also be able to After participants gave their written consent, the researcher or
adapt to this type of educational technology. Accordingly, this research assistants randomly assigned them to the smartphone
study focused on the smartphone, which is predicted to increase website or leaet by a permuted block method to ensure that
in ownership rate among the population, and consequently approximately equal numbers of women was allocated to each
develop a smartphone website supporting perineal massage group. The group allocation was concealed in the numbered sealed
practice. opaque envelope which was developed by a statistician. Partici-
pants were asked not to reveal their group assignment to any
medical staff and other pregnant women.
1.2. Purpose
2.5. Data collection
To develop and evaluate two educational materials (a
smartphone website vs a leaet) to support antenatal perineal
When eligible women at 3033 weeks gestation visited the
massage for primiparous women.
hospital for their prenatal checkup, they were recruited by the
researcher or research assistants. If the woman consented to
1.3. Hypothesis participate, she was provided with a written informed consent
form to sign. After participants signed the informed consent form,
The hypothesis of this study was if primiparous women used a the researcher or the research assistant gave participants a pre-test
smartphone website, they would; (1) continue antenatal perineal questionnaire, a diary and a post-test questionnaire, as well as
massage practice until childbirth, (2) feel the effects of the either instructions for the smartphone website for the smartphone
massage, (3) improve childbirth self-efcacy, (4) indicate satisfac- website group (S-web group) or a leaet about perineal massage
tion with efforts towards childbirth and (5) decrease perineal for the leaet group (LF group). Women in both groups completed
trauma following childbirth compared with those who used a the pre-test questionnaire around the 34th week of gestation and
leaet. put the questionnaire in the envelope and then into the collection
432 S. Takeuchi, S. Horiuchi / Women and Birth 29 (2016) 430435

box or in the post. All participants were asked to record in a diary practice of prenatal perineal massage was completed. This four-
indicating whether they or their partner had done the massage. factor scale consists of 17 items; enjoyment and easiness of the
After giving birth, all participants completed the post-test massage (6 items), effect of preparation for childbirth (6 items),
questionnaire and put it in the envelope and into the collection effect of massage on delivery (3 items) and relationship with
box or in the post. Numbers were written on the questionnaires to partner (2 items) ranging from 1 (not at all) to 6 (very much). The
match the pre-test and the post-test questionnaire. Cronbachs alpha was .926 indicating high internal consistency.
Questions that asked whether women would perform the
2.6. Interventions massage during their next pregnancy and whether they would
recommend perineal massage to other pregnant women were the
2.6.1. Smartphone website same as the original. Childbirth self-efcacy was measured using
The smartphone website was developed based on results of a the childbirth self-efcacy scale developed by Kameda et al.41 This
literature review by the researcher so that pregnant women could scale measures outcome expectancies and self-efcacy expectan-
recognise the effectiveness of antenatal perineal massage and cies to cope with childbirth. This scale consists of 26 items for
continue the massage until childbirth. The contents contained ve outcome expectancies and 26 items for self-efcacy expectancies.
elements as follows: (1) information about the effects of antenatal Validity and reliability of this scale was conrmed.41 Items were
perineal massage; (2) information about the massage technique; rated using a ve-point Likert scale, the higher the points, the
(3) support by a peer group; (4) communication with a higher outcome expectancies or self-efcacy expectancies. For
professional and (5) reminders and encouragement. Information- this study, the coefcient alpha of outcome expectancies was
about the effects of antenatal perineal massage and the massage .947 and self-efcacy expectancies was .939 indicating high
technique consisted of basic knowledge. A message board was internal consistency. A visual analogue scale was used to rate
set to communicate with other pregnant women sharing the their satisfaction with efforts towards childbirth was used.
same situation as support by a peer group. In addition, an inquiry Demographics and obstetric data were also collected by the
form was available so that participants could ask a professional medical record.
questions at any time as communication with a professional.
Moreover, participants received e-mails, which included the 2.8. Analysis
form that reported frequency of practicing the massage each
week as a reminding notication. The woman received an e-mail All analyses were carried out through SPSS version 21.0J. as
of encouragement according to the number of times of their follows: (1) descriptive statistics were used to summarise the
massage practice. Five women who had experienced birth and participants characteristics; (2) Chi-square test was used to
midwives who had the experience of guiding antenatal perineal compare categorical data and t-test was used to compare
massage tested the face validity and the content validity of the continuous data if participants characteristics differed among
smartphone website. Women in the S-web group were asked the S-web group and the LF group and (3) Chi-square test and
to register themselves as a member at the website. The women t-test were used to compare the outcomes of the S-web group
could login into the website after receiving an email of and the LF group. The primary outcome was analysed by both an
registration completion. When the women used the website, intention to treat analysis and a per protocol analysis. Moreover,
reminding notications were sent out once a week. When a secondary outcomes were examined by a per protocol analysis.
woman inputted an inquiry form, the researcher received the All statistical tests were done using a two-sided 5% level of
inquiry and replied. signicance.

2.6.2. Leaet 3. Results

The researcher developed a leaet of information about
perineal massage based on textbooks at hospitals and prenatal The ow of participants for data collection is shown in
magazines. These contents contained two elements as follows: (1) Fig. 1. There were 190 meeting the eligibility criteria during the
information about the effects of antenatal perineal massage and (2) study period and of those 29 refused to participate. Therefore
information about the massage technique. 161 eligible women were randomly assigned to either the S-web
Women in both groups were advised to practice the massage group (n = 81) or the LF group (n = 80). Finally, 47 (58.0%) in the
after 34 weeks gestation, 510 min per day and 34 times per S-web group and 49 (61.3%) in the LF group completed all
week. questionnaires.
Baseline characteristics and birth outcomes were similar in the
2.7. Measures both groups (Tables 1 and 2).

2.7.1. Primary outcome 3.1. Continuance rate

The primary outcome was continuance rate of antenatal
perineal massage practice, collected by a diary. Primary outcome of continuance rate of perineal massage is
shown in Table 3. The rates by a per protocol analysis were 51.1%
2.7.2. Secondary outcome (24/47) in the S-web group and 51.0% (25/49) in the LF group,
The Japanese version of womens opinions on the practice of respectively. There was no signicant difference between the
prenatal perineal massage was used to assess evaluation of groups (x2(1) = .000, p = .997). Moreover, the rates by an intention
antenatal perineal massage. The researcher developed this scale to treat analysis were 29.6% (24/81) in the S-web group and 31.3%
after permission to produce a Japanese version was obtained from (25/80) in the LF group. There was no signicant difference
the original author, Labrecque et al.,40 womens opinions on the between the groups (x2(1) = .050, p = .823).
practice of prenatal perineal massage was translated into Japanese
and a bilingual speaker who was a native speaker of English 3.2. Evaluation of perineal massage
produced a reverse translation. The questionnaire was re-
evaluated by a discussion with a nursing researcher based on its The Japanese version of womens opinions on the practice
results, and the Japanese version of womens opinions on the of prenatal perineal massage score was compared between the
 S. Takeuchi, S. Horiuchi / Women and Birth 29 (2016) 430435 433

Fig. 1. Flow of participants for data collection.

two groups. The mean score of the scale was 52.3 (SD = 15.41) in massage to other pregnant women. There was no signicant
the S-web group and 51.7 (SD = 14.41) in the LF group, respectively. difference between the groups (x2(3) = 2.91, p = .406).
There was no signicant difference between the groups
(t(92) = .187, p = .852). 3.3. Childbirth self-efcacy
The majority of women (68.1% in the S-web group and 72.3%
in the LF group, respectively) reported that they would massage The mean score of outcome expectancies was 93.4 (SD = 13.81)
again for the next delivery, and 6.4% in the LF group and 0% in the S-web group and 94.1 (SD = 16.79) in the LF group,
of the S-web group had no intention of doing the massage respectively. There were no signicant differences in those score
again. between the groups (t(123) = .544, p = .587).
Approximately half of women (56.8% in the S-web group and
53.2% in the LF group, respectively) would recommend the 3.4. Satisfaction with efforts towards childbirth

Satisfaction with efforts towards childbirth in the S-web group

Table 1 was 76.0 (SD = 17.99), and those in the LF group was 71.1
Baseline characteristics of women according to study groups. (SD = 19.80), respectively. There was no statistical signicance
S-web LF (t(90) = 1.28, p = .212).
(n = 47) (n = 49)

Age(yr): mean [SD] 32.7 [4.59] 32.5 [4.18]

Educational level: n (%)
Junior high school or high school 4 (8.5) 1 (2.0) Table 2
Diploma 7 (14.9) 13 (26.5) Birth outcomes of women according to study groups.
Undergraduate 33 (70.2) 30 (61.2)
S-web LF
Graduate 3 (6.4) 5 (10.2)
(n = 47) (n = 49)
Opinion about perineal laceration: n (%)
Not acceptable 7 (14.9) 5 (10.2) Type of delivery: n (%)
If possible 38 (80.9) 40 (81.6) Spontaneous 35 (74.5) 38 (77.6)
Acceptable 2 (4.3) 4 (8.2) Assisted delivery 6 (12.8) 5 (10.2)
Opinion about episiotomy: n (%) Caesarean section 6 (12.8) 6 (12.2)
Not acceptable 2 (4.3) 2 (4.2) Gestational age at delivery 39.4 [1.28] 39.2 [1.31]
If necessary 22 (46.8) 31 (64.6) (wk): mean [SD]
Acceptable 23 (48.9) 15 (31.3) Duration of labour (min): 704.7 [522.28] 631.0 [430.98]
Interest in perineal massage practice: n (%) mean [SD]
Strong 13 (27.7) 18 (36.7) Mean birth weight (g): 3049.7 [303.31] 3071.1 [404.06]
Moderate 30 (63.8) 29 (59.2) mean [SD]
Little 4 (8.5) 2 (4.1) Position in the second stage of labour: n (%)
Childbirth self-efcacy (self-efcacy expectancy): mean [SD] Lithotomy position 37 (90.2) 35 (81.4)
Total scale score 86.5 [15.29] 88.4 [13.86] Lateral position 4 (9.8) 4 (9.3)
Preparation for coping with 33.3 [7.90] 33.0 [6.86] Hands and knees posture 0 (0.0) 4 (9.3)
childbirth and emotional control Apgar score at 1 min: n (%)
Preparation for labour pain and 22.8 [3.21] 24.4 [2.75] 38 points 45 (95.7) 67 (93.9)
acceptance of support 27 points 2 (4.3) 4 (6.1)
Preparation for childbirth in my own way 17.1 [3.42] 17.9 [3.50] Apgar score at 5 min: n (%)
Preparation for judgement a symptom 13.4 [3.66] 13.2 [2.71] 38 points 45 (95.7) 48 (98.0)
of onset and coping behaviour 27 points 2 (4.3) 1 (2.0)
434 S. Takeuchi, S. Horiuchi / Women and Birth 29 (2016) 430435

Table 3 in the massage group to encouragement to continue the massage.

Continuance rates of perineal massage practice according to study groups.
While these studies provided ongoing communication between
Per protocol analysis S-web LF p value participants and professionals, this was lacking in the study
(n = 47) (n = 49) described here. Therefore, besides just giving instructional
n (%) n (%)
material, what is needed is follow-up such as conrming whether
Massaged 33 times and 3 weeks 24 (51.1) 25 (51.0) .997 pregnant women performed the massage or whether they had
Massaged 31 time and 3 weeks 41 (87.2) 41 (83.7) .621 some questions about the massage at the prenatal checkup.
Intent to treat analysis S-web LF p value
(n = 81) (n = 80) 4.2. Secondary outcomes
n (%) n (%)

Massaged 33 times and 3 weeks 24 (29.6) 25 (31.3) .823 Evaluation of perineal massage, childbirth self-efcacy, satis-
Massaged 31 time and 3 weeks 41 (50.6) 41 (51.3) .936 faction with efforts towards childbirth, perineal trauma were
measured as secondary outcomes. Firstly, there was no signicant
difference in evaluation of perineal massage between the groups
Table 4 presumably because women in both groups performed perineal
Perineal outcomes according to study groups.
massage and continuance rates in both groups were similar.
S-web LF p value Secondly, there were no signicant differences in childbirth self-
(n = 41) (n = 43) efcacy and satisfaction with efforts towards childbirth. Takeuchi
Perineal outcome: n (%) and Horiuchi11 reported that self-efcacy, childbirth in my own
Intact 4 (9.8) 2 (4.6) way, of primiparous women who practiced perineal massage was
First-degree 3 (7.3) 9 (20.9) signicantly larger than who did not practice. However, previous
Second-degree 10 (24.4) 9 (20.9) .449
studies reported that physical exercise or acquisition of the
Episiotomy 24 (58.5) 23 (53.5)
Third-degree 0 (0.0) 0 (0.0) knowledge of childbirth during pregnancy were also associated
with childbirth self-efcacy,45,46 accordingly perineal massage
practice is only one of the factors inuencing these self-efcacy
3.5. Perineal outcomes variables. Materials in this study did not have enough of a
signicant effect to inuence these variables. Lastly, there were no
Perineal outcomes in both group are shown in Table 4. Among differences between the groups in perineal outcomes following
women who delivered vaginally, episiotomies rates in both groups childbirth. The episiotomy rates in both groups were over 50% in
were high, 58.5% in the S-web group and 53.5% in the LF group, this study. Shimada44 found that the episiotomy rate in the
respectively. There was no signicant difference in perineal massage group was reduced by 21%. If the episiotomy rate were to
outcome between the groups (x2(4) = 3.70, p = .449). Severe be reduced from 50% to 30% when women continue perineal
perineal lacerations (third and fourth degree lacerations) did not massage, the sample size needed would be 93 women in each
occur in either group. Most women who delivered vaginally and group to detect a difference between the groups at a 5% level
had perineal trauma received suturing (92.7% in the S-web group of signicance with 80% power. Therefore, an increased sample
and 97.7% in the LF group, respectively). There was no signicant size is needed in order to verify the effects of perineal massage on
difference between the groups (x2(1) = 1.15, p = .283). perineal outcomes following childbirth.

4. Discussion 4.3. Limitations and suggestions for future studies

4.1. Primary outcome: continuance of antenatal perineal massage This study was limited in several ways. Firstly, among women
who completed all questionnaires, almost all women performed
In this study, continuance rates (three times a week over a three perineal massage. There might be participants motivation or
week period) were 51.1% in the S-web group and 51.0% in the LF interest in perineal massage as confounding factors of this study.
group by a per protocol analysis and 29.6% in the S-web group and Secondary, The number of required subjects was compromised
31.3% in the LF group by an intention to treat analysis. In previous because the withdrawal rate was high (44.4% in S-web group and
studies, among women who received information about perineal 38.8% in LF group, respectively). The researcher sent reminder mails
massage through textbooks at hospitals or prenatal magazines, the to participants who did not answer the questionnaires. However, the
rates of women who perform the massage over three times a week mail did not lead to the desired response rate. In this study, the
until childbirth were 12.915.9%.11 Moreover, it was reported researcher gave participants the post-test questionnaire when
that continuance rates of perineal massage were 2.95.4% participants signed the informed consent form. However, it might be
among women who receive no massage instruction.42,43 Therefore, a better strategy for the researcher to have participants report their
continuance rates in this study were higher than the results of delivery and then researchers hands the post-test questionnaire
those studies. Furthermore, in the previous studies, pregnant directly to the participant or has it sent by post after childbirth.
women received information about the massage by themselves; on Moreover, it might be need to devise such as providing an incentive
the other hand, in this study, communication with a professional every time when participants report frequency of practicing the
happened when the researcher provided information for partici- massage each week or asking directly when they visit the hospital for
pants. This communication between participants and a profes- their prenatal checkup in order to keep response rate. In the future, it
sional might have had an effect on continuance of the massage. will be important to continue to keep in touch with the participants
In previous studies, among women who received instruction because the researcher did not regularly communicate with each
about perineal massage, the continuance rate in Labrecque participant in this study. Moreover, sample size was calculated
et al.s42 study was 65.1% and the rate in Shimadas44 study was based on the study of breastfeeding website, which compared the
76.7%. Therefore, the rate in this study was lower compared with website to usual care. However, in this study, the website was
these studies. Shimada44 checked on whether participants compared to a leaet. Therefore, not only the withdrawal rate was
performed the massage by self-report diary, telephone and asking high, but also sample size might be small because a leaet was more
at the prenatal checkup. Labrecque et al.42 also telephoned women effective than usual care.
 S. Takeuchi, S. Horiuchi / Women and Birth 29 (2016) 430435 435

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