NCT07085026

Brief Summary

Many physiological and psychological changes occur during pregnancy. Sleep and stress are among these changes and can negatively impact the pregnancy process. Yoga can improve sleep quality and stress levels during pregnancy. The purpose of this study was to evaluate the effects of yoga, implemented in the third trimester of pregnancy according to World Health Organization guidelines, on sleep and stress.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

July 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

August 21, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

August 22, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 17, 2025

Last Update Submit

August 21, 2025

Conditions

Keywords

yogasleepstresspregnancythird trimester

Outcome Measures

Primary Outcomes (1)

  • Sleep Quality

    Sleep quality is measured by the Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) was developed to assess sleep quality and sleep disturbances over the past month. It consists of a total of 24 questions, 19 of which are self-rated items. The remaining 5 questions are used for clinical evaluation and are not included in the scoring. Each item in the scale is rated on a scale from 0 to 3. From the 19 self-rated items, 7 component scores are derived. Some components are based on a single item, while others are formed by combining several items. These components are: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The total score of the scale is obtained by summing the scores of these 7 components. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A total score greater than 5 indicates "poor sleep quality."

    It will be assessed at baseline (in the third trimester of pregnancy) and on day 30 after the yoga intervention.

Secondary Outcomes (1)

  • Perceived Stress Level

    It will be assessed at baseline (in the third trimester of pregnancy) and on day 30 after the yoga intervention.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in this group will practice yoga in accordance with the WHO guideline recommendations.

Behavioral: Yoga Intervention

Control Group

NO INTERVENTION

Participants in this group will not receive yoga; routine care will be provided.

Interventions

There are studies that have evaluated the effects of prenatal yoga on sleep. None of these studies have reported any negative effects of yoga on pregnancy. In all studies, yoga practice was applied with varying frequencies, durations, and techniques. However, no research has been found that evaluates the effects of a yoga program conducted in accordance with the World Health Organization (WHO) guideline recommendations on both sleep and stress. Therefore, the aim of this study is to evaluate the effects of yoga, practiced during the third trimester of pregnancy in line with WHO guideline recommendations, on sleep and stress.

Intervention Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Voluntarily agreed to participate in the study,
  • Aged between 18 and 35 years,
  • In the third trimester of pregnancy (between 29 and 42 weeks of gestation),
  • Able to read and write in Turkish,
  • No prior experience with yoga practice.

You may not qualify if:

  • High-risk pregnancy,
  • In the first or second trimester,
  • Multiple pregnancy,
  • Any condition that prevents yoga practice (e.g., restrictions on physical activity),
  • Previous experience with yoga practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine Prof. Dr. Murat Dilmener Hospital

Istanbul, Bakirköy, 34140, Turkey (Türkiye)

RECRUITING

Study Officials

  • Tülay TÜLAY Yılmaz, Associate Professor

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Central Study Contacts

Gözde GÖZDE Şengün, Undergraduate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Because of the behavioral and observable characteristics of the intervention (yoga in the third trimester of pregnancy), neither assessment nor blinding of investigators was performed.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Pregnant participants will be randomly assigned to two groups in a 1:1 ratio. The intervention group will receive a yoga program in accordance with the WHO guideline recommendations, while the control group will receive no intervention and will continue with routine care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Degree Student with Thesis, Istanbul University- Cerrahpasa Midwifery Department

Study Record Dates

First Submitted

July 17, 2025

First Posted

July 25, 2025

Study Start

August 21, 2025

Primary Completion

February 1, 2026

Study Completion

April 1, 2026

Last Updated

August 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations