This randomized control trial was done on first time pregnant women attending six governmental antenatal clinics of healthcare centers of Zanjan city, Iran. In order to select antenatal clinics, the antenatal clinics of healthcare centers of the Zanjan divided into three regions based socio-economic variables. Then, 2 clinics were randomly selected from each region. To collect data from a homogeneous group of first time pregnant women, a number of inclusion and exclusion criteria were considered.
The inclusion criteria were being: 1) 18 to 35 years old, 2) able to speak and read Persian (since some women were from the less privileged parts of Zanjan province in which all people do not speak Persian and did not have enough reading and speaking language skills), 3) having a single fetus, 4) scoring ≥ 66 on the Wijma Delivery Expectancy/Experience Questionnaire (23), and 5) first time pregnancy. Women were excluded if they had any history of infertility, and mental or physical chronic diseases.
2.1. Sample size
Based on the mean and standard deviation of scores on the childbirth fear reported for the intervention (36. 3± 8) and control groups (30.6±8.6) in the previous study (24), power = .80, and error of type 1 = .05, the sample size of 34 was calculated for each group. Considering the 20% attrition rate, sample size of 40 was estimated for each group.
2.2. Data collection
A number 171 first time pregnant women who were in 20th to 23th week of pregnancy and consecutively attended the antenatal clinics were recruited in this study between February to September of 2019. They were informed by the midwives of the clinics about this research. Those who signed a written consent were recruited. At first, they were asked to complete Wijma Delivery Expectancy/Experience Questionnaire (WDEQ) (23). Among them, 91 women were excluded (32 women did not report childbirth fear, and 59 women did not meet inclusion criteria). Thus, 80 first time pregnant women with childbirth fear were recruited in the study.
They were randomly assigned into two groups: the intervention (n = 40) or control groups (n = 40) via block randomization method using 4-way blocks. The randomization code was generated by a web-based randomization system. The assessors and data analyzer were blinded to the group allocation. Five participants in the intervention group and 7 participants in the control group dropped out from the study because immigration, preterm childbirth, death of the fetus, and Incidence of diabetes (Figure 1). Both groups answered demographic information questionnaire, Wijma Delivery Expectancy/Experience Questionnaire (23), and Childbirth Self Efficacy Inventory (25) at pretest and post-test.
2.2.1. Sociodemographic questionnaire: This included age, education level, and occupation.
2.2.2. childbirth preference was assessed trough following question:” Which method do you prefer for the child birth? A: Normal vaginal birth, B: caesarean section”.
2.2.3. Wijma Delivery Expectancy/Experience Questionnaire-A (WDEQ-A): The questionnaire assesses the intensity of emotions related to the expectations of the childbirth. It consists of 33 items on a 6-point Likert scale (0 = do not agree; 5 = totally agree) (23). The total score ranges from 0 to 165 and higher scores reflect greater level of childbirth fear. A score ≥ 66 reflects sever childbirth fear. Women are asked to answer items while imagining how labor and delivery are going to be, and how they expect 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 the current study, internal consistency of the WDEQ-A was .86.
2.2.4. Childbirth Self-Efficacy Inventory (CBSEI): This 62-item questionnaire was developed to assess maternal confidence in coping abilities during labour (25). Women were asked to answer the questions based on a ten-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) Self-Efficacy Expectancy Second Stage (Efficacy-SS): items 47–62. The two total scores are: (i) the total child birth outcome expectancy score (outcome total), which is computed by summing the Outcome AL and Outcome SS scale scores and (ii) the total self-efficacy expectancy score (efficacy total), which is computed by summing the Efficacy AL and Efficacy SS scale scores. The higher scores reflect greater level of childbirth self-efficacy. Validity and reliability of the Persian version (28) of the CBSEI was established. In the current study, internal consistency of the scale was .98.
2.3. Procedure
The intervention group received two face-to-face counseling sessions by the first author (she is a midwife) in the 24th week and 34th week of pregnancy. Between this two counseling sessions, intervention group had 8 weekly telephone counseling sessions. The intervention approach was based on the BELIEF approach. The BELIEF is a telephone psychoeducation counseling approach that offered by midwives. The intervention emphasized on the women’s expectations and emotions about childbirth fear, expression of feelings, providing a structure for women to identify and work through distressing components of childbirth (19). The intervention helps women to develop individualized supports for the present and near future, affirming that negative events can be coped with simple problem solving skills. Third and fourth authors, who are professors of clinical psychology, trained and supervised the first author on how to do the intervention. The Persian version of the protocol can be accessed from the corresponding author. The sessions were randomly recorded and listened by the fourth author to make sure that the intervention is in accordance with the principles of the BELIEF protocol. The control group only received routine prenatal care. A midwife who was blinded to group assignment did the pre-test and post-test assessments (Figure 1).
2.4. Data analysis
The statistical analysis was done with the statistical package for social sciences (SPSS) software version 24. The probability value’s significance level was 0.05. The demographic characteristics of the participants were estimated with descriptive statistics. Independent t-test and Chi-square test was used to compare the two groups regarding the socio-demographic characteristics. Shapiro-Wilk test showed that the dependent variables have a normal distribution among the groups (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 2 groups on the child birth fear, childbirth self-efficacy, childbirth preference.
2.5. Ethical considerations
The study was registered in the registry for clinical trials (IRCT20101219005417N3). The ethics committee of Zanjan University of Medical Sciences approved the procedure of the research (IR.ZUMS.REC.1397.025). Participants signed a written consent before participating in the study and they could exit at any stage of the research.