NCT06897072

Brief Summary

The aim of this study was to determine the effect of yoga on mode of delivery preference, labour satisfaction and neonatal outcomes. This study was planned as a randomised controlled experimental study. The population of the study will consist of pregnant women who apply to the childbirth preparation classes of the institutions affiliated to the Bucak District Health Directorate, who meet the inclusion criteria and accept to participate in the study. The sample of the study; It will consist of pregnant women who apply for pregnancy follow-up to the birth preparation class determined between the dates of the study (15.01.2025 - 30.04.2025), who meet the criteria for admission to the study and who accept the study. The sample number was calculated by performing power analysis with the G power programme (19) and taking a study as a reference (20). According to the power analysis, the sample size was determined as 80 people (40 experimental, 40 control) to reach 95% power with an effect size of 0.8 and a 5% margin of error.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

January 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 20, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

March 20, 2025

Last Update Submit

March 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Birth Satisfaction Scale Revised Form (BSS-R)

    In order to evaluate birth satisfaction, the Birth Satisfaction Scale Revised form (BSS-R) developed by a researcher was adapted into Turkish and a validity and reliability study was conducted. The BSS-R is a 5-point Likert-type scale. It is scored as strongly disagree '0 points', disagree '1 point', undecided '2 points', agree '3 points', strongly agree '4 points'. The lowest score of 0 and the highest score of 40 points can be obtained from the scale. In the scale, 6 statements are positive, 4 statements are negative and 4 items are reverse scored. The reverse scored items are items 2, 4, 7, 8. The higher the score obtained from the scale, the higher the woman's satisfaction with childbirth. In this study, the Cronbach's alpha reliability coefficients of the scale were 0.72 for BSS-R total, 0.78 for 'Quality of Care Services', 0.71 for 'Stress Experienced in Trauma', and 0.70 for 'Personal Characteristics of Women'.

    up to 24 weeks

Secondary Outcomes (1)

  • Scale of Pregnant Women's Preferences for Mode of Delivery

    up to 24 weeks

Study Arms (2)

Yoga

EXPERIMENTAL

It was planned to exclude those who did not accept to participate in the study, who were diagnosed with risky pregnancy, who were illiterate, who had systemic disease and mental problems requiring treatment, who had a gestational week less than 26-28, and who had communication and language problems. After the sampling is completed, the aims of the study will be explained to all pregnant women and they will be included in the study if they are satisfied. Participants in the experimental group will start the first pregnancy yoga session between the 26th and 28th weeks of pregnancy and attend the last session at the 37th week of pregnancy. They will practice yoga twice a week (each session lasting 75 minutes) in childbirth preparation classes

Behavioral: Yoga

Control

NO INTERVENTION

The control group will receive the routine antenatal care that all pregnant women receive.

Interventions

YogaBEHAVIORAL

In the experimental group, yoga exercises were performed for 50 minutes with physical yoga movements (Vrksasana (tree pose), janusirsasana (head-knee pose), modifiedmarichyasana (great sage pose), baddhakonasana (connected angle pose), malasana (garland pose), sukhasana (meditation pose), ardhapadmasana (lotus sitting pose), gomukhasana (cow face pose), supta matyendrasana (spinal rotation pose on the back), bharmanasana (table pose), chakravasana (cat/cow pose), dandayamanabharmasana (balancing yoga pose), vajrasana (diamond pose), viraphadrasana 1-2 (warrior 1-2 pose). The class will include 15 minutes of meditation (deep relaxation with a focus on breath and self-awareness), breathing exercises in between and 10 minutes of relaxation.

Yoga

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being a woman
  • who had a gestational week over than 26-28

You may not qualify if:

  • who did not accept to participate in the study,
  • who were diagnosed with risky pregnancy,
  • who were illiterate,
  • who had systemic disease and mental problems requiring treatment, who had a gestational week less than 26-28, and
  • who had communication and language problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burdur Mehmet Akif Ersoy University

Burdur, Turkey (Türkiye)

Location

Related Publications (3)

  • Koyuncu SB, Bulbul M. The impact of yoga on fear of childbirth and childbirth self-efficacy among third trimester pregnants. Complement Ther Clin Pract. 2021 Aug;44:101438. doi: 10.1016/j.ctcp.2021.101438. Epub 2021 Jul 8.

  • Pais M, Pai MV, Kamath A, Bhat R, Bhat P, Joisa GH. A Randomized Controlled Trial on the Efficacy of Integrated Yoga on Pregnancy Outcome. Holist Nurs Pract. 2021 Sep-Oct 01;35(5):273-280. doi: 10.1097/HNP.0000000000000472.

  • Van der Riet P, Francis L, Rees A. Exploring the impacts of mindfulness and yoga upon childbirth outcomes and maternal health: an integrative review. Scand J Caring Sci. 2020 Sep;34(3):552-565. doi: 10.1111/scs.12762. Epub 2019 Dec 3.

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
They did not know if they were in the control and intervention group at the time of randomization.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 20, 2025

First Posted

March 26, 2025

Study Start

January 15, 2025

Primary Completion

February 15, 2025

Study Completion

September 15, 2025

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

All authors contributed to the interpretation, writing, and approval of the final manuscript.

Locations