NCT07031622

The Effect of Yoga on Mental Health and Trauma in Pregnant Women

Determining the Effect of Yoga Exercises on Psychological Health and Childbirth Trauma in Pregnant Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Sakarya University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the effects of prenatal yoga exercises on psychological health and the perception of traumatic birth in pregnant women. The study will evaluate whether a structured yoga program can reduce anxiety, improve psychological resilience, and decrease the perception of birth-related trauma during pregnancy and postpartum periods. Study Design: A pre-post test matched group model will be used to investigate the effects of yoga exercises. The study includes an intervention group receiving prenatal yoga training in addition to standard birth preparation education, and a control group receiving only the birth preparation education. Population and Sample: The study will be conducted with pregnant women applying to the obstetrics outpatient clinic of a women's and children's hospital. Eligible participants will be over 18 years of age, over 16 weeks pregnant, have a planned pregnancy, and no diagnosis of high-risk pregnancy. Exclusion criteria include hypertension, gestational diabetes, short cervical length, and low-lying placenta. A power analysis (Type I error of 0.05, Type II error of 0.20, effect size = 0.80) determined the required sample size as 26 per group, increased to 62 in total to account for potential dropouts.

Detailed description

Title: The Effect of Yoga on Mental Health and Trauma in Pregnant Women Study Description (Brief Summary): This study aims to investigate the effects of prenatal yoga exercises on psychological health and the perception of traumatic birth in pregnant women. The study will evaluate whether a structured yoga program can reduce anxiety, improve psychological resilience, and decrease the perception of birth-related trauma during pregnancy and postpartum periods. Study Design: A pre-post test matched group model will be used to investigate the effects of yoga exercises. The study includes an intervention group receiving prenatal yoga training in addition to standard birth preparation education, and a control group receiving only the birth preparation education. Population and Sample: The study will be conducted with pregnant women applying to the obstetrics outpatient clinic of a women's and children's hospital. Eligible participants will be over 18 years of age, over 16 weeks pregnant, have a planned pregnancy, and no diagnosis of high-risk pregnancy. Exclusion criteria include hypertension, gestational diabetes, short cervical length, and low-lying placenta. A power analysis (Type I error of 0.05, Type II error of 0.20, effect size = 0.80) determined the required sample size as 26 per group, increased to 62 in total to account for potential dropouts. Intervention: The intervention group will attend a 5-week prenatal yoga program comprising 10 sessions (2 sessions/week, 45 minutes/session). Each session includes mindful breathing, yoga asanas, and meditation. Both groups will receive the same standard birth preparation education. Randomization and Blinding: Participants will be randomly assigned to intervention and control groups using simple randomization. The study is single-blind: participants will know their group, but intervention implementers and data analysts will be blinded. Outcome Measures: Data will be collected using the following tools: Participant Information Form (demographic and obstetric characteristics) Brief Psychological Resilience Scale (BPSR) Traumatic Childbirth Perception Scale (TCPS) Childbirth Trauma Index Scale (CTIS) Post-Traumatic Stress Scale - Short Version State-Trait Anxiety Inventory (STAI) These scales will be administered pre-intervention, post-intervention, and at 7 and 40 days postpartum. Data Analysis Plan: Data will be analyzed using SPSS. Descriptive statistics will summarize demographic and clinical variables. Paired and independent t-tests will compare within and between-group differences. Repeated measures ANOVA will be used to assess changes in trauma perception and anxiety over time. A significance level of p\<0.05 will be applied. Ethical Considerations: The study will be conducted following ethical principles. Ethical approval has been or will be obtained from the relevant Institutional Review Board (IRB), and informed consent will be obtained from all participants.

Conditions

• Yoga Exercises

Interventions

Type	Name	Description
OTHER	Yoga Exercises	The control and intervention groups received birth preparation training for 45 minutes one day a week for 5 weeks. The experimental group additionally received a total of 10 sessions of a yoga program for 45 minutes, 2 days a week. The content of each yoga session included 10 minutes of mindful breathing, 20 minutes of yoga asanas, and 15 minutes of meditation.

Timeline

• Start date: 2023-11-01
• Primary completion: 2023-11-30
• Completion: 2024-11-30
• First posted: 2025-06-22
• Last updated: 2025-06-22

Locations

1 site across 1 country: Turkey (Türkiye)