Comparing the effect of group- based training along with text messaging and compact disc- based training on men’s knowledge and attitude about participation in perinatal care: a cluster randomized control trial

This study was a cluster randomized control trial with three groups (intervention 1, intervention 2 and control groups). The population of this study includes husbands of pregnant women (with gestational age of 20–22 weeks) who referred to three midwifery clinics affiliated to the Social Security Organization of Tabriz city, East Azerbaijan province, Iran from May to August 2018. There were a large number of pregnant women and their husbands with the same socio-economic status who referred to these clinics. Also, it was easier to access pregnant women and their husbands in these places. In this study to determine how many samples are needed to create a good chance of finding an effect (if the effect really exists) and considering that the minimum recommended value for the test power is 80%, we considered a test power of 95%. Based on the confidence interval of 95%, a test power of 95% (using G-power software), and considering a sample loss rate of 10%, sample size of 24 was estimated for each group.

The inclusion criteria were husbands of pregnant women with gestational age of 20–22 weeks, lack of participation of men in any educational intervention or training about men’s participation in perinatal care, living with their wife, and no problem in relationships between couples (by asking participants). The exclusion criteria were unwillingness to continue to cooperate at any stage of the research and lack of full participation of men in the training sessions held in group- based training along with text messaging.

In the present study for preventing interactions and relationships between participating men about the interventions, the three midwifery clinics were randomly assigned to intervention (group- based training along with text messaging and CD- based training (and control groups by first author (VF). In this regard, one of the midwifery clinics was selected for group- based training along with text messaging, another clinic for CD- based training group and third clinic for control group. In the midwifery clinics, using convenience sampling, the medical files of 120 pregnant women were evaluated and participants who had the inclusion criteria were selected (Fig. 1). Then, after making phone calls to them, other inclusion criteria were asked and the time for their husband visit was settled. After visiting 75 eligible men and assuring them of the confidentiality of their information, written informed consent was obtained from all the participants (Fig. 1). The researcher performed the group- based training using different training methods (speech, displaying images, sharing the members’ experiences, and question and answer), board and computer in two sessions each lasting for 2 h with one-week interval on Fridays. At the end of the second session, the men were notified to receive health messages via mobile at their desired time. From the day after the second group education session, three to four health text messaging were sent weekly (about the participation of men in perinatal care) up to 3 months after the intervention. After the second group training session, the researcher distributed a CD among men of the CD-based training group about men participation in perinatal care (contents were similar to those provided at group-based training). This CD consisted of the training text, questions, images, and voices. Training content included changes in women’s body during pregnancy and the role of men in women’s adaption to these changes; common complaints during pregnancy and men’s role in women adaption to them; the men’s participatory role in perinatal care; the father’s relationship with the fetus and the mother; preparation for childbirth and fatherhood; danger signs during pregnancy and how to deal with them; the role of men in delivery process; social support and its consequences during pregnancy, childbirth and postpartum; The role of men in providing social support for pregnant women, during childbirth and postpartum; psychological support for pregnant women and in postpartum period; postpartum grief and men’s supportive role; postpartum depression and the role of men; barriers to men’s participation during pregnancy, childbirth, and postpartum and its remedies. Valid scientific books, articles, and websites were applied for preparation of the training contents [2, 26‐31]. In this study, no action was taken for the control group.

The primary outcomes included men^, s knowledge and attitude about their participation in perinatal care that were measured by a researcher-made questionnaire. The content of questions on men’ s knowledge and attitude about their participation in perinatal care were based on training content. This questionnaire was completed by the participants at two stages (before the intervention and 3 months after the intervention). The aforesaid questionnaire contained three sections: demographic characteristics, knowledge measurement, and attitude measurement. Knowledge measurement tool consisted of 28 multiple choice questions and the score of one was assigned to each “correct” answer. For “incorrect” and “not sure” answers, a score of zero was considered. The minimum score of zero and the maximum score of 28 were considered for the knowledge measurement tool. An example of a knowledge assessment question was: “When a man talks to his pregnant wife about her worries, it reduces her anxiety”. Attitude measurement tool had 23 questions with 5-point Likert scale (totally agreed, agreed, I have no idea, disagreed, totally disagreed). The assigned scores for measuring negative attitude were: 0 for totally agreed, 1 for agreed, 2 for I have no idea, 3 for disagreed and 4 for totally disagreed. Furthermore, the assigned scores for measuring positive attitude were: 4 for totally agreed, 3 for agreed, 2 for I have no idea, 1 for disagreed and 0 for totally disagreed. The minimum score of zero and the maximum score of 92 were considered for the attitude measurement tool. An example of an attitude assessment question was: “The duty of a man during pregnancy and postpartum is just work outside the home and earning an income”.

Content validity method was used to approve the validity of the data collection tools and test-retest method was applied for its reliability. Cronbach’s alpha coefficients for knowledge and attitude questionnaires were 0.71 and 0.89, respectively. The intra-cluster correlation coefficients (ICC) for knowledge and attitude questionnaires were 0.88 (95% CI = 0.59–0.96) and 0.98 (95% CI = 0.94–0.99), respectively that indicated the stability of the questionnaires.

Statistical analysis of the present study was conducted using SPSS 23 software. The Chi-square, one-way ANOVA, Kruskal-Wallis and Fisher’s exact tests were used for assessing the consistency of the three groups in terms of socio-demographic characteristics. To compare mean score of men^, s knowledge and attitude about participation in perinatal care in each group paired t-test was used before and after the intervention. To compare the mean score of men^,s knowledge and attitude about participation in perinatal care between the three groups one-way ANOVA was used before the intervention. To compare the mean score of men^,s knowledge and attitude about participation in perinatal care between the three groups ANCOVA test was used after the intervention. The significance level for statistical tests was considered less than 0.05 (P < 0.05).

This study was registered in the registry for clinical trials (IRCT20160224026756N4). The Ethics Committee of Isfahan University of Medical Sciences approved the protocol of this study (code number: IR.MUI. Rec.1395.3.599) and written informed consent, anonymity, confidentiality and the right of leaving the research at any desired time were preserved.

The results showed that the mean (SD) score of men^, s knowledge and attitude about participation in perinatal care were not significantly different between the three groups before the intervention (p = 0.944, p = 0.228, respectively). The results showed that the mean (SD) score of men^, s knowledge (p < 0.001) and attitude (p = 0.005) about participation in perinatal care had a significant increase in group- based training along with text messaging after the intervention compared to the score of before the intervention, but the mean score of men^, s knowledge and attitude had not a significant increase in CD- based training and control group after the intervention compared to the score of before the intervention (Table 2). Also, the mean (SD) score of men^,s knowledge (P < 0.001) and attitude (P = 0.011) about participation in perinatal care had a significant difference between the three groups after the intervention (Table 3).

The results showed that the mean (SD) score of men^,s knowledge and attitude about participation in perinatal care in group- based training along with text messaging were significantly higher than in CD- based training (p < 0.001, p = 0.039, respectively) and control group (p = 0.001, p = 0.021, respectively) after the intervention, respectively. However, the mean (SD) score of men^, s knowledge and attitude in CD- based training were not significantly different from the control group (Table 4).

One of the strengths of this study is the implementation of educational intervention on men’s knowledge and attitude about participation in perinatal care, for the first time, and almost all the principles of clinical trial, were observed to prevent selection bias. In the present study, coordinating with participating men to attend clinics for trial registration and also attend sessions in group- based training required frequent phone calls, which was time consuming. In this regard, 20 days before the intervention, participating men were repeatedly contacted and invited to register. Also, reminder text messages were sent to attend the training sessions on time.

One of the limitations of this research is individual differences between participating men in learning educational materials; therefore, this may affect data collection. The results of this trial may not be generalizable, because other settings, with different participants, and differing extents of training or motivation of healthcare providers could produce different results.