- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07585916
Prenatal Yoga Intervention in Pregnant Women
Effects of a Prenatal Yoga Intervention on Traumatic Childbirth Perception, Self-Perception, and Delivery Preferences in Pregnant Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be conducted with voluntary pregnant women aged 18 years and older, at or beyond the 16th week of gestation, and without a diagnosis of high-risk pregnancy. Participants will be randomly assigned to the intervention and control groups using a computer-generated simple randomization method (https://www.random.org/integers/
) to ensure unbiased allocation. The intervention group will consist of 8-12 participants per group, and the program will be implemented in three separate groups. Participants in the intervention group will receive a prenatal yoga program consisting of eight sessions delivered twice weekly, while the control group will receive routine prenatal care without any additional intervention from the researchers. Data collection instruments will be administered at baseline (pre-test), at the end of the eighth session (post-test), and at a one-month follow-up.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Duygu Özer, Asst. Prof
- Phone Number: +905061291978
- Email: duyguozer2016@hotmail.com
Study Locations
-
-
Bartın
-
Bartın, Bartın, Turkey (Türkiye), 74100
- Recruiting
- Bartın University
-
Contact:
- Duygu Özer, Asst. prof
- Phone Number: +9 05061291978
- Email: duyguozer2016@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being at or beyond the 16th week of gestation (second trimester or later)
- Being aged 18 years or older
- Having no diagnosis of high-risk pregnancy based on obstetric evaluation
- Having no medical restriction on physical activity or yoga practice as determined by a physician
- Providing written informed consent after being informed about the study
Exclusion Criteria:
- Diagnosis of high-risk pregnancy (e.g., preeclampsia, placenta previa, premature rupture of membranes, risk of preterm birth, or other serious obstetric complications)
- Physician-imposed restriction on physical activity
- Presence of serious systemic conditions that would prevent participation in yoga practice
- Inability to complete the questionnaires reliably due to psychiatric or cognitive conditions
- Declining to participate or not providing informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
Prenatal Yoga Program was applied to the intervention group.
|
Participants in the intervention group received a structured prenatal yoga program consisting of eight sessions delivered twice weekly.
Each session lasted approximately 45 minutes and was conducted in accordance with safe prenatal exercise guidelines.
|
|
No Intervention: Control
Participants in the control group received routine prenatal care only and were not exposed to any structured intervention during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Traumatic Childbirth Perception Scale
Time Frame: Baseline, immediately after the 8-week intervention, and 1 month post-intervention
|
The Traumatic Childbirth Perception Scale is a self-report instrument designed to assess perceptions of traumatic childbirth, including physical, emotional, and psychological aspects.
The scale consists of 13 items.
Each item is rated on a scale ranging from 0 to 10, and total scores range from 0 to 130, with higher scores indicating higher levels of perceived traumatic childbirth.
Mean total scores are used to interpret the level of traumatic childbirth perception.
The score ranges are categorized as follows: 0-26 (very low), 27-52 (low), 53-78 (moderate), 79-104 (high), and 105-130 (very high).
|
Baseline, immediately after the 8-week intervention, and 1 month post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pregnant Women's Self-Perception Scale
Time Frame: Baseline, immediately after the 8-week intervention, and 1 month post-intervention
|
The scale consists of 12 items rated on a 4-point Likert scale ranging from 1 (never) to 4 (always).
It comprises two subscales: maternal perception related to pregnancy (7 items) and body perception during pregnancy (5 items).
Higher scores on the maternal perception subscale (range: 7-28) indicate higher levels of positive maternal perception.
In contrast, higher scores on the body perception subscale (range: 5-20) reflect more negative body perception during pregnancy.
|
Baseline, immediately after the 8-week intervention, and 1 month post-intervention
|
|
Preferred Mode of Delivery Scale for Pregnant Women
Time Frame: Baseline, immediately after the 8-week intervention, and 1 month post-intervention
|
The scale is suitable for women without systemic or psychiatric disorders and who conceived naturally.
It consists of 18 items and three subscales: self-efficacy, normative beliefs, and preferences.
Items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Items 6-14 and 16-18 are reverse scored.
The total score is calculated by summing all item responses, and subscale scores can be obtained by summing the corresponding items.
The scale does not have a cut-off point.
Total scores range from 18 to 90, with higher scores indicating a stronger preference for vaginal delivery, as all items are scored in favor of vaginal birth for ease of interpretation.
|
Baseline, immediately after the 8-week intervention, and 1 month post-intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BARU-SBF-DO-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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