Clinical trial NCT06897072: The Effect of Yoga on Labour and Neonatal Outcomes in Pregnant Women
Official title: The Effect Of Yoga Applied In Childbirth Preparation Classes On Mode Of Delivery Preference, Bırth Satisfaction And Newborn Outcome: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Burdur Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Birth Satisfaction Scale Revised Form (BSS-R)
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Scale of Pregnant Women's Preferences for Mode of Delivery
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur Mehmet Akif Ersoy University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.