Pregnancy RelatedNCT06897072
The Effect of Yoga on Labour and Neonatal Outcomes in Pregnant Women
A study testing Yoga in people with Pregnancy Related, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being a woman
- who had a gestational week over than 26-28
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Pregnancy Related
- Being tested
- Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Yoga |
| Control | No intervention | The control group will receive the routine antenatal care that all pregnant women receive. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: up to 24 weeks
Secondary outcomes (1)
Scale of Pregnant Women's Preferences for Mode of Delivery
The scale was developed to determine the birth preferences of pregnant women based on the Health Belief Model and Planned Behaviour Model. The Turkish validity and reliability study was conducted. The scale is suitable for naturally pregnant women without systemic and psychiatric diseases. The scale consists of 18 items in total and three sub-dimensions (self-efficacy, normative beliefs, preferences). The scale form is 5-point Likert type. Each item in the scale is scored on the options of Strongly Disagree (1), Disagree (2), Undecided (3), Agree (4) and Strongly Agree (5).
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start15 Jan 2025
- Primary completion15 Feb 2025
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SABRIYE UCAN YAMAC, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897072
- Sponsor's protocol ID
- GO 2024/838
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All authors contributed to the interpretation, writing, and approval of the final manuscript.
Publications
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.
PubMed 34252859Pais 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.
PubMed 34407025Van 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.
PubMed 31797402
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06897072
- Acronym / sponsor ID
- GO 2024/838
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: YogaIt 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 |
| Control | No intervention | –The control group will receive the routine antenatal care that all pregnant women receive. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- being a woman
- who had a gestational week over than 26-28
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaIn 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. | Behavioural | Yoga |
Primary outcome
Birth Satisfaction Scale Revised Form (BSS-R)
Time frame: up to 24 weeks
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'.
1 secondary outcome
Scale of Pregnant Women's Preferences for Mode of Delivery
Time frame: up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Results publication: PubMed 34252859Koyuncu 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.
- Results publication: PubMed 34407025Pais 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.
- Results publication: PubMed 31797402Van 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.
- Individual participant dataSharing planned: No. All authors contributed to the interpretation, writing, and approval of the final manuscript.
Related trials for Pregnancy Related
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Pregnancy Related, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth Satisfaction Scale Revised Form (BSS-R) (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06897072, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.