We categorized all the antenatal clinics of Zanjan city, Iran, into three regions based on socio-economic variables. Then, two clinics were randomly selected from each region. From February to September 2019, 171 first-time pregnant women referred to these public antenatal clinics.
First-time pregnant women who were between 18 to 35 years old, could speak and read Persian, had a single fetus, and scored 66 or above on the Wijma delivery expectancy/experience questionnaire (W-DEQ) (23) were selected to participate in the study. Those who had any history of infertility, and mental or physical chronic diseases were excluded.
2.1. Sample size
The sample size was estimated as 34 participants for each group according to the mean and standard deviation of childbirth fear scores for the intervention (36.3 ± 8) and control groups (30.6 ± 8.6) of a previous research on Iranian first-time pregnant women who were afraid of giving birth (24), power = .80, and error of type 1 = .05. Predicting 20% attrition rate, the sample size of 40 was calculated for each group.
2.2. Data collection
We initially recruited 171 first-time pregnant women who were in 20th to 23rd weeks of pregnancy. They were informed about the research by the midwives and those who signed a written consent were recruited. At first, they answered the W-DEQ (23). 91 women were excluded (32 women did not show childbirth fear, and 59 women did not meet the inclusion criteria). Thus, 80 first-time pregnant women with childbirth fear participated in the study.
The participants were randomly assigned into intervention (n = 40) or control groups (n = 40). We did the randomization with four-way blocks. The randomization code was produced by a web-based randomization software. The assessors and data analyzer were not aware of the group assignment. 12 women (five in the intervention group and seven in the control group) dropped out of the study because of immigration, preterm childbirth, fetus death, and occurrence of diabetes (Figure 1). All women answered the demographic information questionnaire, W-DEQ (23), and childbirth self-efficacy inventory (25) at pretest and post-test.
2.2.1. The sociodemographic questionnaire included age, educational status, and occupation.
2.2.2. Childbirth preference was assessed with the following question: “Which method do you prefer for giving birth? A) normal vaginal birth, B) caesarean section”.
2.2.3. WDEQ-A: This questionnaire assesses the intensity of emotions related to childbirth expectations. It consists of 33 items on a six-point Likert scale (0 = do not agree; 5 = totally agree) (23). The total score ranges from 0 to 165. Higher scores reflect greater level of childbirth fear. A score ≥ 66 reflects severe childbirth fear. Women are asked to answer the questions while imagining how labor and delivery are going to be, and how they expect it to feel. Items 2, 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27, and 31 are reverse-scored. Reliability and validity of WDEQ-A have been demonstrated in different populations (23, 26), as well as Iranians (27). In our study, internal consistency of the WDEQ-A was .86.
2.2.4. Childbirth self-efficacy inventory: This 62-item questionnaire assesses maternal confidence in coping abilities during labor (25). Women are asked to answer the questions based on a 10-point Likert scale. It has four subscales: (1) Items 1-15 measure outcome expectancy active labor (Outcome-AL); (2) Items 16-30 assess self-efficacy expectancy active labor (Efficacy-AL); (3) Items 31-46 measure expectancy second stage (Outcome-SS); (4) items 47–62 measure self-efficacy expectancy second stage (Efficacy-SS). The two total scores are: (i) the total childbirth outcome expectancy score (outcome total), which is calculated by summing the Outcome AL and Outcome SS scale scores and (ii) the total self-efficacy expectancy score (efficacy total), which is calculated by summing the Efficacy AL and Efficacy SS scale scores. Higher scores reflect greater level of childbirth self-efficacy. Validity and reliability of the Persian version (28) of the Childbirth self-efficacy inventory has been established. In our study, the internal consistency of the scale was .98.
2.3. Procedure
The first author gave two face-to-face counseling sessions in the 24th and 34th weeks of pregnancy to the participants in intervention group (she is a midwife). Between these two sessions, the intervention group received eight telephone-counseling sessions once a week. We used the BELIEF approach which is a telephone counseling psychoeducational approach offered by midwives (19). It helps women to develop individualized support for the present and near future, affirming that negative events can be coped with simple problem-solving skills. The third and fourth authors trained the first author on how to conduct the BELIEF approach. The fourth author randomly listened to the record of the sessions to assure that the intervention is in accordance with the BELIEF protocol (Figure 1).
2.4. Data analysis
We analyzed the data using the statistical package for social sciences (SPSS) software version 24. We used descriptive statistics to describe the demographic characteristics of the participants. The two groups were compared regarding the socio-demographic characteristics using independent t-test and Chi-square test. Shapiro-Wilk test indicated that the variables have a normal distribution (p value ranged from 0.12 to 0.34). Preliminary checks were conducted to ensure that there was no violation of the assumptions of normality, linearity, homogeneity of variances, homogeneity of regression slopes, and reliable measurement of the covariate. Thus, one-way between-groups analysis of covariance was used to determine the differences between the two groups on the childbirth fear, childbirth self-efficacy, childbirth preference.
2.5. Ethical considerations
This study was registered in the registry for clinical trials (IRCT20101219005417N3). The ethics committee of our university approved the research procedure (IR.ZUMS.REC.1397.025). All participants provided a signed written informed consent and they could leave at any stage of the research.