Trial design
This was a four-armed randomized controlled, parallel-design trial.
Participants
We recruited 120 pregnant women referring to Ebnesina private hospital, Tehran- Iran from 2019-2020. The inclusion criteria were being literate, being in gestational age 24 to 32 weeks at recruitment, being able to speak Persian, having no complications in current pregnancy, having no indications for CS, and having enough time to participate in the intervention’s sessions. We excluded women who showed complications during the study and/or had preterm labour. (Figure 1).
Interventions
We had three intervention and one control groups. Educational contents were developed using findings of a qualitative evidence synthesis and a quantitative systematic review and meta- analysis (19) and a qualitative study conducted in Iran (35).
The interventions included: 1) motivational interviewing (IM); 2) information, motivation and behavioral skill model through face-to-face approach (IMB); and 3) information, motivation and behavioral skill model through Mobile App (IMB-App). We designed three-session brief interventions and scheduled them within the participants’ time and prenatal care visit appointments for MI and IMB groups. All MI and IMB sessions were held by a midwife and a behavioral specialist that were trained by a health psychologist (H. P.). The IMB-App was designed in three sessions similar to the IMB group. The first session was accessible to the participants at the time of recruitment. Other session was accessible after the participants practiced the previous session. There were no time scheduling in the IMB-App group.
1. Motivational interviewing (MI)
In this intervention group, pregnant women were interviewed face-to-face during three 45-60 minutes sessions. MI techniques were provided to the participants. MI is a directive, client-centered counseling style for eliciting behavior change by helping clients to explore and resolve ambivalence. It is most centrally defined not by technique but by its spirit as a facilitative style for interpersonal relationship. MI is a relatively simple, transparent and supportive talk therapy based on the principles of cognitive–behavior therapy. In this intervention group, we helped women to explore and resolve ambivalence about mode of delivery and build their intrinsic motivation. We did not force women to choose a specific mode of delivery. We asked open–ended questions (for example “Tell me what you think about CS?" or “What do encourage you to choose this type of delivery (CS or NVD)?”). Open-ended questions could help us to understand how they were thinking about mode of delivery. Affirming is one of the fundamental MI skills. We used it to support engagement, encourage the women to further explore change processes and build confidence. We found an opinion the client was making or a strength she noticed and reflected it back to her (for example” So how did you manage to control your fear after attending our training sessions?(". We used reflective listening. It is a simple method to reduce resistance in MI and the last step of this technique is to summarize what the pregnant women have said (Table 1).
Information, motivation and behavioral skill model through face-to-face approach (IMB)
The model’s strategies were presented to the pregnant women, in three 45-60 minutes sessions. Women have received information and behavioral skills related to the choice of mode of delivery as well as internal and external motivational factors related to the choice of delivery. The strategy included three sessions as follow: Session 1) information: the intervention began with information on prevalence of CS and CS-related complications in women; and outcome of unnecessary CS; Session 2) motivation: the interventionist performed this technique to motivate pregnant women; providing personal feedback, asking open ended questions, affirming desirable behavior, reflective listening, working at the women’s pace and negotiating goals that was realistic and attainable; Session 3) behavioral skills: women were given behavioural skills training on how to control the obstacle of NVD. To build skills for choosing the mode of delivery, training was given on how reduce these barriers. In the last session, final assessment was also conducted (Table 1).
2. Information, motivation and behavioral skill model through Mobile App (IMB-App)
The mobile application (M-health) had designed based on IMB model (flowchart 1 and appendix 1-9). The content was the same as the IMB intervention that was presented in three similar sessions in the Mobile Application. The software was installed on mobile phones of participants in this group; and its operation was taught individually to them. Women worked with the application in presence of one of the researchers, and any existing problems were resolved. The strategies foreseen for adherence improvement included reminders set at defined intervals in the form of pop-up messages. In order to monitor adherence, the data collected on the server were used. In addition to the application, a server was designed in which the users’ activities were collected. Items such as the duration of application usage, the sections were used by the user (in addition to registering their time and duration) (appendix10), etc. was registered. Every time the user’s mobile was connected to the Internet, the data was uploaded and saved on to the server. These data could be used as a proxy of adherence to the intervention.
Table 1: Interventions by four study groups
Training session
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MI1 group
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IMB2 group
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IMB-App3 group
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Control group
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First session
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Familiarization: Introduction, norms and group process, facilitating philosophy, practice of freedom, practice of dimensions of effect of behavior, practice of change of assessment change.
Emotions: Identifying emotions, exercising and completing practice dimensions of influence with emotional dimensions and homework
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Information: introducing and explaining the program of norms and standards of the group, asking questions to start the discussion about CS and NVD, rate of CS, prevalence of CS, risk factors for CS, consequences of unnecessary CS, NVD
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Same as IMB group
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Usual antenatal care
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Second session
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Pros and cons of the CS and NVD: brainstorming of short-term and long-term pros and cons of the CS, completing table of the pros and cons of the CS and NVD, describe and practice about the NVD
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Motivation: asking open ended questions about unnecessary CS, providing personal feedback, reasons for needing to change current behaviour, feedback and affirmation, affirming desirable behavior, reflective listening, working at the women’s pace and negotiating goals that was realistic and attainable and empowerment to change behaviour, summarizing, discussing.
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Same as IMB group
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Usual antenatal care
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Final session
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Values, Perspective and Final Assessment: Defining values (what is the important thing for women?), identification and prioritization of first class values, adaptation of value and mode of delivery, summarizing and summarizing practice of previous sessions in perspective practice training be prepared to start a behaviour change program (decision about NVD). Final measurement.
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Behavioural Skills: how they should cope with NVD, and how they can control themselves problem with NVD and conclusion. Final measurement.
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Same as IMB group
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Usual antenatal care
Final measurement.
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1 Motivational Interviewing; 2 Information, Motivation, Behavioral Skill Model; 3 Information, Motivation, Behavioral Skills Model through mobile application
Outcomes
Primary outcome of the study was the mode of delivery. The secondary outcomes were women’s intention to undergo CS and women’s self-efficacy. The outcomes questionnaires along with the demographic and obstetrics characteristics were administered after the recruitment of the participants. The outcomes were measured once again at the end of last sessions.
Self-efficacy is a belief that individuals have about themselves’ ability to cope with stressful situations and implement necessary actions successfully. There is a known relationship between fear of childbirth, self-efficacy and NVD; if a pregnant woman believes that she cannot deal with labor situation, her fear and anxiety will lead her to choose CS without medical indications (57).
Regarding intention to choose a mode of delivery, we asked women about their intention about their mode of delivery at baseline and at the end of last session.
Sample size
The sample size was calculated to be 120 pregnant women (30 women in each group) with the type I error (alpha) of 0.05 and a test power of 80% to detect a minimum difference of at least 20% in the rate of CS by the intervention. Considering that the rate of CS in the control group is 50%, which in previous reports was 47.9% (116), the number of samples in each group was determined with 95% confidence.
Randomization
The participants were randomly assigned to four groups after the initial assessment and upon completing the baseline measurement. We recruited the participants based on registration order of women with clinic, and no other factor contributed to the participants’ order on the list. Each participant on the list assigned a consecutive research identification number according to the order by which they were registered with the clinic. The first participant on the list was randomly assigned to the MI intervention group, and the next two participants were assigned to the IMB and IMB-App interventions, respectively. The forth group of participants was assigned to the control group.
Blinding
To avoid bias in the outcome assessment, researchers concerned with data collection and/or preparation were blind to the allocation of the participants.
Measures
The questionnaires contained the women’s demographic information, self-efficacy to choose mode of delivery, and intention behavior. The validity and reliability of the questionnaires have been examined and verified (58, 59). The demographic section included items on age, income, educational level (pregnant women and their partners), employment status (pregnant women and their partners), number of births, number of pregnancies, current gestational age (at recruitment), number of live children, history of infertility, history of illness, date of birth, participating in birth classes, and preferred mode of delivery. The questionnaire also consisted of 17 items about self-efficacy and two items about intention to choose mode of delivery. The Cronbach’s coefficient alpha was calculated to test the reliability; and exploratory factor analysis was conducted to examine construct validity of the Persian version of the questionnaires.
Follow-up: We followed the participants until time of delivery to determine final mode of delivery. The pregnant women were participated in this study after ensuring that they had study criteria. They completed informed consent forms. In the first visit, the baseline data questionnaire was completed by the researcher. During the second visit, the application was installed on cell phones of the IMB-App group and its operation was taught to them.
Statistical methods: Data were analyzed using SPSS 16 using descriptive statistics (mean, frequency and standard deviation), inferential statistics including Two-independent-t-test
Paired-t-test, Chi-squared test and analysis of variance (ANOVA) modeling to examine the factors affecting the women’s choice on mode of delivery in order to examine the simultaneous effect of variables on the chances of choosing CS. The significance level of the tests was less than 0.05.
Role of the funding source: The roles of the funders were to monitor the corresponding research planning and progression.