NCT07031622

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
Last Updated

June 22, 2025

Status Verified

November 1, 2023

Enrollment Period

29 days

First QC Date

June 4, 2025

Last Update Submit

June 12, 2025

Conditions

Keywords

Childbirth traumapregnancyyogamidwifeexercise

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

EXPERIMENTAL

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.

Other: Yoga Exercises

control

NO INTERVENTION

No 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.

Experimental group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Bartın University

Bartın, Bartın, 74100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

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
Model Details: In addition, preliminary information was shared with all potential participants at the beginning of the interviews were given detailed information about the research, and informed consent forms were signed. 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. No yoga program was applied to the control group, and psychological assessments were not conducted. tests were performed during the same period as the experimental group. The research data for the experimental and control groups were collected from pregnant women who met the inclusion/exclusion criteria.
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

Locations