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
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2024
CompletedFirst Submitted
Initial submission to the registry
June 4, 2025
CompletedFirst Posted
Study publicly available on registry
June 22, 2025
CompletedJune 22, 2025
November 1, 2023
29 days
June 4, 2025
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pre-test post-test
This study was conducted using the "pre-post test matched group model" to investigate the effects of yoga exercises on the reduction or prevention of childbirth trauma.
1 year
Study Arms (2)
Experimental group
EXPERIMENTALThe 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.
control
NO INTERVENTIONNo intervention will be made to the control group. Only measurements will be made on parallel dates with the experimental group.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Over 18 years old
- Over 16 weeks
- Without a diagnosis of high-risk pregnancy
- Not exercising before pregnancy
- Planned pregnancy
You may not qualify if:
- Hypertension
- Gestational diabetes
- Short cervical length
- Low-lying placenta
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sakarya Universitylead
- Bartın Unıversitycollaborator
Study Sites (1)
Bartın University
Bartın, Bartın, 74100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- In this study, after the participants agreed to participate, they were assigned to the intervention and control groups using the simple randomization method. In the randomization process, participants were assigned odd and even numbers according to the order of application to the center. Those given odd numbers formed the intervention group. In contrast, those given even numbers formed the control group. This method was used to ensure equal distribution of the groups and to prevent selection bias. In the blinding process, the study was conducted with a single-blind design. Participants knew which group they were in, but the researchers who implemented the intervention and the statistical expert who analyzed the data were unaware of the groups' distribution, except for the person who performed the randomization. Thus, observer bias and assessment bias were minimized during the statistical analysis phase. This method was preferred to prevent factors that may affect participation in the i
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
June 4, 2025
First Posted
June 22, 2025
Study Start
November 1, 2023
Primary Completion
November 30, 2023
Study Completion
November 30, 2024
Last Updated
June 22, 2025
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share