The effect of mindfulness-based stress reduction on maternal anxiety and self-efficacy: A randomized controlled trial.

Abstract Objective The aim of the study was to assess the effect of mindfulness‐based stress reduction (MBSR) on anxiety and self‐efficacy in coping with childbirth. Material and Methods This randomized controlled trial was conducted on 70 pregnant women in Abyek city of Qazvin province in Iran. The convenient sampling method was recruited. Samples were assigned to control and intervention groups using random blocks. In addition to routine care, individuals in the intervention group received 6 MBSR training sessions. The data gathering questionnaire in this study included mindfulness, Pregnancy‐Related Anxiety Questionnaire, and self‐efficacy in coping with childbirth questionnaire. Results There was no statistically significant difference between the demographic characteristics in the control and intervention groups. The results of the analysis of variance (ANOVA) with repeated measures indicated the effect of time on the change in the total score of anxiety in the intervention group (p = .001). There was a significant difference between the two groups (p = .001). Also, the results of ANOVA with repeated measures showed that time had no impact on the score of self‐efficacy in delivery coping (p = 0/1) and that there was no significant difference between the two groups in this respect (p = .6). Conclusion The result of this study showed that mindfulness reduces anxiety of pregnant mothers, and it is suggested that mindfulness programs be educated for healthcare providers and pregnant mothers to reduce maternal anxiety and improve pregnancy outcomes and delivery.

duction programs have been performed as a clinical trial during pregnancy, and only limited studies have focused on mind-body approach, advanced muscle relaxation, yoga, and meditation to reduce maternal stress to improve maternal health and pregnancy outcomes (Guardino, Dunkel Schetter, Bower, Lu, & Smalley, 2014).
The results of systematic review studies on the effect of mindfulness have shown a favorable trend and that no significant differences have been shown in the effect of mindfulness on anxiety, depression, and perceived stress. Due to the scarcity of trial studies, more research is needed to investigate the effect of mindfulness on stress and anxiety during pregnancy (Dhillon et al., 2017). The aim of the present study was to assess the effect of mindfulness based on stress reduction on the self-efficacy and stress of pregnant women.

| MATERIAL AND ME THOD
This study was a randomized controlled trial study. Participants in this study consisted of pregnant women with a first 24-to 36week pregnancy referring to Abyek Comprehensive Health Services Centers. The Abyek Comprehensive Health Service Center is one of health centers in Qazvin province in Iran, where pregnant women referred to it.
Sample size with 95% confidence interval, 90% power and probability sample dropping, were estimated 35 per group.
In the intervention group, 3 women were excluded from the study due to lack of participation in more than two sessions of counseling sessions and 2 women excluded due to preterm labor. Moreover, in the control group, 3 women were excluded from the study due to preterm labor, intrauterine death, and immigration. Finally, the study was continued with 30 subjects in the control group and 30 in the intervention group ( Figure 1).

| Inclusion criteria
Being Iranian, fluent in Persian, first pregnancy, wanted pregnancy, 24-to 36-week pregnancy, single fetus, and lack of pregnancy complications (diabetes, preeclampsia, etc).

| Exclusion criteria
Nonparticipation in 2 full sessions of counseling, known medical conditions, psychological problems, abortion history, intrauterine death, preterm labor, participate in yoga classes, relaxation, and having cesarean section indications.
After approving study from Alborz university deputy research, written informed consent was obtained from all of mothers. The convenient sampling method was recruited. The samples were randomly assigned to each groups using randomized blocks: counseling (intervention) and without counseling (control). There were six probabilities for placing in blocks (BABA, BBAA ABBA, AABB, ABAB, and BAAB). At the beginning of the study, one of the blocks was selected and 4 participants were placed in that block, so that number A was assigned to the intervention group and number B belonged to the control group.
After determining the groups, before the onset of the study, pregnancy anxiety, self-efficacy of coping with childbirth, and mindfulness questionnaire was completed in both groups.

| Intervention
In the intervention group, pregnant women received 6 group counseling sessions (7-person groups) twice a week, and each session lasted for 60 min in a lecture, question and answer, and role play based on the MBSR (Hauck, Fisher, Byrne, & Bayes, 2016). In addition to receiving weekly counseling, daily home-based mindfulness methods were advised to the intervention group via telephone and social networks, and any questions were answered by the researcher. The researcher was a graduate student in midwifery coun-

| Data analysis
In this research, data were analyzed using SPSS software version 16. Normality of data distribution was assessed by the Kolmogorov-Smirnov test. t Test was used to compare quantitative variables between the two groups. Comparison of qualitative variables was performed using chi-square and Fisher's exact test. To compare pregnancy anxiety score, self-efficacy of coping with childbirth, and mindfulness in two groups before, immediately, and 1 month after intervention, analysis of variance with repeated measures was used.
Data analysis was performed on the basis of preprotocol analysis.

| Ethical considerations
The present study was approved by the Ethics Committee with the code number (Abzums.Rec.1396.152) and recorded in the clinical trial system with the code number IR CT20150119020719N9.
Before the onset of the study, the study objectives and the confidentiality of all information were explained to the participants. All participants signed informed consent to participate in the research and the researcher tried to consider all the moral rights of the research samples.

| RE SULTS
Demographic characteristics of pregnant women mentioned in Table 1.

The results of analysis of variance with repeated-measures test
showed that the length of time affects the total score of mindfulness (p = .001) and there is a significant difference between the two groups (p = .001) ( Table 2).
The results of analysis of variance with repeated measures in assessing the changes in pregnancy anxiety score before, immediately after, and 1 month after the intervention showed that the length of time affects the anxiety score of pregnancy (p = .03) and that a significant difference was observed between the two groups in this regard (p = .001) ( Table 2).
The results of analysis of variance with repeated measures in examining the changes in self-efficacy scores before, immediately after, and 1 month after the intervention showed that the length of time did not affect the self-efficacy score (p = 0. 1) and that there was no significant difference between the two groups (p = .69) ( Table 2).

| D ISCUSS I ON
Mindfulness sessions had an effect on the reduction of anxiety. The results of this study are in line with those obtained in other studies.
In a study, Yazdani Mehr and et al showed the effect of 8 sessions of cognitive-behavioral-based mindfulness program on stress and depression in pregnant mothers (Yazdanimehr, Omidi, Sadat, & Akbari, 2016). The results of another 6-session counseling showed anxiety reduction in the intervention and control group, but the anxiety reduction was reported more in the intervention group. In mentioning study, 30% of the participants in the control group stated that they participated in pregnancy yoga classes that may indicate the lack of a significant difference between the two groups (Guardino et al., 2014). The results of another study showed that pregnant women who participated in yoga classes and meditation for 3 hr once a week for 9 weeks increased mindfulness and decreased stress, anxiety, and their negative effects (Duncan & Bardacke, 2010). In a study in Australia, the effect of a mindfulness program in a randomized study on 32 pregnant women and in a nonrandomized study of 20 pregnant women was shown to reduce stress, anxiety, and depression, although there was no significant difference between the two groups (Woolhouse, Mercuri, Judd, & Brown, 2014). In a study, the mindfulness mobile app was designed to prepare the mental and emotional health of pregnant mothers and their husbands for childbirth and parenting transition. This app was designed to promote mental health and to resilience parents to childbirth and mental changes; however, it was not reported to be highly effective in people with severe psychological problems (Bakker, Kazantzis, Rickwood, & Rickard, 2016).
A qualitative study with the aim of explaining the experiences of mothers who had received the mindfulness during the pregnancy showed that many of the mothers considered mindfulness as a valuable preparation to confront the challenges of pregnancy, childbirth, and acceptance of parental roles, concerning stress, anxiety, and pain (Lönnberg, Nissen, & Niemi, 2018).
The results of this study showed anxiety reduction in the control group. It can be concluded that the three questionnaires of mindfulness, anxiety, and self-efficacy by mothers simultaneously can lead to mother's awareness of their condition. Also, the progression of pregnancy in the control group increases the experience of pregnancy and stress reduction. In this study, participants were advised not to participate in other research and group classes during the course of the study. The study limitations were the inability to control information from other sources of information such as the Internet and attendance at health centers, which may reduce the stress score in the intervention group.
The results of this study showed that the self-efficacy score was not significantly different immediately after intervention with before intervention; however, it was significant in 1 month after the intervention, which could be due to a higher decrease in stress in 1 month after the intervention. The results of a quasi-experimental study showed the effect of mindfulness and empowerment model education on reducing stress and fear and improving self-efficacy and delivery outcomes. The authors have declared the integration of mindfulness with a skill education to be a serious approach to improve delivery outcomes. It should be noted that the low number of the samples and the absence of control groups were subject to research limitation (Byrne et al., 2014). In the present study, the effect of mindfulness on anxiety and self-efficacy was investigated.
Mindfulness after intervention did not affect the self-efficacy in coping with childbirth. According to the results of study, it is recommended that further research show the effect of blending mindfulness and skills-based prenatal education program on self efficacy. In this intervention, none of the participants in the intervention group participated in childbirth preparation classes. The self-efficacy score increased in 1 month after intervention compared to before and after intervention. Since maternal anxiety scores were also reduced in 1 month after, it is suggested that this variable be considered as one of the effective factors in mindfulness studies. It is also suggested that the mindfulness home work that is recommended to be done at home be emphasized and evaluated more reliable. So, in this area, it is possible to record the workouts at home by the participants.

| CON CLUS ION
This study showed that mindfulness reduces anxiety of pregnant mothers, and it is suggested that mindfulness programs be educated for healthcare providers and pregnant mothers so as to reduce maternal anxiety and improve pregnancy outcomes and delivery.

ACK N OWLED G M ENTS
We thereby appreciate Clinical research and Development center of the Kamali Hospital for its material and spiritual support.

CO N FLI C T O F I NTE R E S T
None declared.

AUTH O R CO NTR I B UTI O N
Sara Esmaelzadeh is a supervisor and designed and performed the study; Masoomeh Zarenejad is a student who performed the study; Zahra Mehdizadeh designed and consulted about the proposal; Mansooreh Yazdkhasti designed and gave counseling about the content of the proposal and paper; and Mitra Rahimzadeh is a biostatistician and gave counseling about sampling and analysis of data.

DATA AVA I L A B I L I T Y S TAT E M E N T
The data that support the findings of this study are available in the supplementary material of this article.