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IRCT20250801066718N1 IRCT 2025-08-16 Iran University of Medical Sciences Mindfulness Program on Fear of Childbirth and Depression in Pregnancy The Effect of Mindfulness Based on Childbirth Program on Fear of Childbirth and Depression in Pregnant Women 2025-08-14 anticipated 94 Complete https://irct.ir/trial/85528 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible participants will be continuously enrolled in the study. They will then be randomly assigned in blocks of four to either the intervention group (mindfulness based on childbirth program) or the control group (routine prenatal education and care). The randomization sequence will be generated using the SealedEnvelope website, Blinding description: In this study, the data analyst will be blinded to the group allocation (intervention or control) and will receive only coded data for statistical analyses. N/A Condition 1: Perinatal depression. Condition 2: Fear of Childbirth. Intervention 1: This study was designed as an educational–psychological intervention with an intervention group (mindfulness based on childbirth program) and a control group (routine prenatal care and education) in 2025 . At the first visit, all mothers (both control and intervention groups) in the 15th–22nd weeks of pregnancy, or during gatherings in the waiting room, were provided with the necessary information about the study, the existing groups, and its objectives.Mothers in the intervention group, who were randomly selected during the visit, could voluntarily choose their preferred session times according to the schedule if they were willing to participate. After signing the informed consent form and receiving the necessary explanations, the Perceived Stress Questionnaire was completed by the intervention group. If the score obtained from the questionnaire was above 28 and the inclusion criteria were met, the mother was enrolled in the intervention.The measurement tools included the Wijma Delivery Expectancy/Experience Questionnaire, the Edinburgh Postnatal Depression Scale, and the Five Facet Mindfulness Questionnaire. The scores obtained from these questionnaires were assessed and recorded before the intervention.In the intervention group, women were divided into subgroups of 7-10 participants, each consisting of both multiparous and primiparous women. Eligible mothers in the intervention group attended in-person mindfulness sessions once a week for a total of eight sessions, and the data were documented in the relevant checklist. The intervention was delivered in person, once a week, for three hours per session, over eight consecutive weeks. Session 1: Introduction to mindfulness, physiology of pregnancy and childbirth, and discussion of the culturally meaningful value of present-moment awareness. Raisin meditation practice.Session 2: Recognising bodily sensations, thoughts and emotions, the physiological stress response (fight-or-flight), responding to pregnancy-related fears, and practising patience when facing pregnancy-related challenges. Body scan practice.Session 3: Coping with pain and discussion of the culturally meaningful value of trust in God as a supportive coping resource. Ice exercise and mindful breathing during discomfort.Sessions 4–6: Understanding the childbirth process and labour pain, applying mindfulness to unpleasant sensations and uncertainty, and recognising and using emotional and practical support from family members. Yoga, mindful family inquiry about fear and joy, and sitting meditation.Session 7: Integrating mindfulness into childbirth and early parenting and cultivating self-compassion. Loving-kindness meditation.Session 8: Reviewing the entire course and practising previously learned mindfulness skills. Continued independent mindfulness practice, applying mindfulness to daily activities and childbirth-related experiences, and daily gratitude journaling. Intervention 2: Control group: At the first visit, all mothers (both control and intervention groups) in the 15th–22nd weeks of pregnancy, or during gatherings in the waiting room, were provided with the necessary information about the study, the existing groups, and its objectives. The control group received only routine prenatal care and education. Mothers in the control group who were randomly selected during the visit, after completing the informed consent form and receiving the necessary explanations, completed the Perceived Stress Questionnaire. If the score obtained from the Perceived Stress Questionnaire was above 28 and the inclusion criteria were met, the mother was enrolled in the study.The measurement tools included the Wijma Delivery Expectancy/Experience Questionnaire, the Edinburgh Postnatal Depression Scale, and the Five Facet Mindfulness Questionnaire, which were completed by the control group mothers before the start of the intervention and again eight weeks later. The obtained scores from these questionnaires were then analyzed. At post-intervention assessment, participants in the intervention group had significantly lower fear of childbirth and depression scores and significantly higher mindfulness scores than those in the control group, after adjusting for baseline scores. The between-group differences were significant for fear of childbirth (F(1,84)=16.19, p<0.001, η²p=0.162), depression (F(1,84)=7.90, p=0.006, η²p=0.086), and mindfulness (F(1,84)=8.90, p=0.004, η²p=0.096). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information available
public Dr. Nahid Akbari
School of Nursing & Midwifery Rashid Yasemi St. Valiasr St. Tehran- Iran
Tehran Iran (Islamic Republic of) ۱۹۹۶۷۱۳۸۸۳ 0098 21 8882886 akbari1420@gmail.com Iran University of Medical Sciences scientific Badriyeh Daniyali
Unit 4, Hadis 1 Building, Alley 3, Ayatollah Sadr St., Molavi Blvd., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7145891675 +98 917 429 7246 badrieh.dn@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Perceived Stress Score equal to or greater than 28 Singleton pregnancy Gestational age between 15 and 22 weeks Maternal age above 18 years Ability to attend all educational sessions Ability to read and write in Persian Iranian ethnicity of the mother Normal maternal body mass index (BMI) Full consciousness and adequate hearing and speaking ability to receive training and respond to questions 18 years no limit Female Alcohol and drug addiction Any history of mindfulness training or meditation History of previous fetal anomaly History of maternal treatment with anticonvulsants, antidepressants, thyroid hormones, and cortisone History or current presence of medical disorders History of serious psychiatric disorders, including psychotic disorders, bipolar disorder, depression, and medication use confirmed by a physician (based on the medical history obtained by the researcher from the pregnant mother and the information documented in her medical record). F53.0 Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified Other Other This study was designed as an educational–psychological intervention with an intervention group (mindfulness based on childbirth program) and a control group (routine prenatal care and education) in 2025 . At the first visit, all mothers (both control and intervention groups) in the 15th–22nd weeks of pregnancy, or during gatherings in the waiting room, were provided with the necessary information about the study, the existing groups, and its objectives.Mothers in the intervention group, who were randomly selected during the visit, could voluntarily choose their preferred session times according to the schedule if they were willing to participate. After signing the informed consent form and receiving the necessary explanations, the Perceived Stress Questionnaire was completed by the intervention group. If the score obtained from the questionnaire was above 28 and the inclusion criteria were met, the mother was enrolled in the intervention.The measurement tools included the Wijma Delivery Expectancy/Experience Questionnaire, the Edinburgh Postnatal Depression Scale, and the Five Facet Mindfulness Questionnaire. The scores obtained from these questionnaires were assessed and recorded before the intervention.In the intervention group, women were divided into subgroups of 7-10 participants, each consisting of both multiparous and primiparous women. Eligible mothers in the intervention group attended in-person mindfulness sessions once a week for a total of eight sessions, and the data were documented in the relevant checklist. The intervention was delivered in person, once a week, for three hours per session, over eight consecutive weeks. Session 1: Introduction to mindfulness, physiology of pregnancy and childbirth, and discussion of the culturally meaningful value of present-moment awareness. Raisin meditation practice.Session 2: Recognising bodily sensations, thoughts and emotions, the physiological stress response (fight-or-flight), responding to pregnancy-related fears, and practising patience when facing pregnancy-related challenges. Body scan practice.Session 3: Coping with pain and discussion of the culturally meaningful value of trust in God as a supportive coping resource. Ice exercise and mindful breathing during discomfort.Sessions 4–6: Understanding the childbirth process and labour pain, applying mindfulness to unpleasant sensations and uncertainty, and recognising and using emotional and practical support from family members. Yoga, mindful family inquiry about fear and joy, and sitting meditation.Session 7: Integrating mindfulness into childbirth and early parenting and cultivating self-compassion. Loving-kindness meditation.Session 8: Reviewing the entire course and practising previously learned mindfulness skills. Continued independent mindfulness practice, applying mindfulness to daily activities and childbirth-related experiences, and daily gratitude journaling. Control group: At the first visit, all mothers (both control and intervention groups) in the 15th–22nd weeks of pregnancy, or during gatherings in the waiting room, were provided with the necessary information about the study, the existing groups, and its objectives. The control group received only routine prenatal care and education. Mothers in the control group who were randomly selected during the visit, after completing the informed consent form and receiving the necessary explanations, completed the Perceived Stress Questionnaire. If the score obtained from the Perceived Stress Questionnaire was above 28 and the inclusion criteria were met, the mother was enrolled in the study.The measurement tools included the Wijma Delivery Expectancy/Experience Questionnaire, the Edinburgh Postnatal Depression Scale, and the Five Facet Mindfulness Questionnaire, which were completed by the control group mothers before the start of the intervention and again eight weeks later. The obtained scores from these questionnaires were then analyzed. Depression score in the Edinburgh Questionnaire. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Edinburgh Postnatal Depression Scale (EPDS). Fear of Childbirth score in the Wijma Questionnaire. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Wijma delivery expectancy questionnaire (W-DEQ (A)). Mindfulness score on the Five Facet Mindfulness Questionnaire. Timepoint: Before the intervention and immediately after the intervention. Method of measurement: Five Facet Mindfulness Questionnaire. Self-funded by the researcher Approved 2024-08-11 Research Ethics Committees of Iran University of Medical Sciences Deputy of Research and Technology, Central Headquarters Building, Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)