Yoga ExercisesNCT07031622
The Effect of Yoga on Mental Health and Trauma in Pregnant Women
A study testing Yoga Exercises in people with Yoga Exercises, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effects of prenatal yoga exercises on psychological health and the perception of traumatic birth in pregnant women. The study will evaluate whether a structured yoga program can reduce anxiety, improve psychological resilience, and decrease the perception of birth-related trauma… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Yoga Exercises
- What is being tested?
- Yoga Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Over 18 years old
- Over 16 weeks
- Without a diagnosis of high-risk pregnancy
- Not exercising before pregnancy
- Planned pregnancy
Who cannot join
- Hypertension
- Gestational diabetes
- Short cervical length
- Low-lying placenta
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Effect of Yoga Exercises on Psychological Health and Childbirth Trauma in Pregnant Women
This study aims to investigate the effects of prenatal yoga exercises on psychological health and the perception of traumatic birth in pregnant women. The study will evaluate whether a structured yoga program can reduce anxiety, improve psychological resilience, and decrease the perception of birth-related trauma during pregnancy and postpartum periods.
Study Design:
Read more
A pre-post test matched group model will be used to investigate the effects of yoga exercises. The study includes an intervention group receiving prenatal yoga training in addition to standard birth preparation education, and a control group receiving only the birth preparation education.
Population and Sample:
The study will be conducted with pregnant women applying to the obstetrics outpatient clinic of a women's and children's hospital. Eligible participants will be over 18 years of age, over 16 weeks pregnant, have a planned pregnancy, and no diagnosis of high-risk pregnancy. Exclusion criteria include hypertension, gestational diabetes, short cervical length, and low-lying placenta.
A power analysis (Type I error of 0.05, Type II error of 0.20, effect size = 0.80) determined the required sample size as 26 per group, increased to 62 in total to account for potential dropouts.
Read the detailed description
Title: The Effect of Yoga on Mental Health and Trauma in Pregnant Women
Study Description (Brief Summary):
This study aims to investigate the effects of prenatal yoga exercises on psychological health and the perception of traumatic birth in pregnant women. The study will evaluate whether a structured yoga program can reduce anxiety, improve psychological resilience, and decrease the perception of birth-related trauma during pregnancy and postpartum periods.
Study Design:
A pre-post test matched group model will be used to investigate the effects of yoga exercises. The study includes an intervention group receiving prenatal yoga training in addition to standard birth preparation education, and a control group receiving only the birth preparation education.
Population and Sample:
The study will be conducted with pregnant women applying to the obstetrics outpatient clinic of a women's and children's hospital. Eligible participants will be over 18 years of age, over 16 weeks pregnant, have a planned pregnancy, and no diagnosis of high-risk pregnancy. Exclusion criteria include hypertension, gestational diabetes, short cervical length, and low-lying placenta.
A power analysis (Type I error of 0.05, Type II error of 0.20, effect size = 0.80) determined the required sample size as 26 per group, increased to 62 in total to account for potential dropouts.
Intervention:
The intervention group will attend a 5-week prenatal yoga program comprising 10 sessions (2 sessions/week, 45 minutes/session). Each session includes mindful breathing, yoga asanas, and meditation. Both groups will receive the same standard birth preparation education.
Randomization and Blinding:
Participants will be randomly assigned to intervention and control groups using simple randomization. The study is single-blind: participants will know their group, but intervention implementers and data analysts will be blinded.
Outcome Measures:
Data will be collected using the following tools:
Participant Information Form (demographic and obstetric characteristics)
Brief Psychological Resilience Scale (BPSR)
Traumatic Childbirth Perception Scale (TCPS)
Childbirth Trauma Index Scale (CTIS)
Post-Traumatic Stress Scale - Short Version
State-Trait Anxiety Inventory (STAI)
These scales will be administered pre-intervention, post-intervention, and at 7 and 40 days postpartum.
Data Analysis Plan:
Data will be analyzed using SPSS. Descriptive statistics will summarize demographic and clinical variables. Paired and independent t-tests will compare within and between-group differences. Repeated measures ANOVA will be used to assess changes in trauma perception and anxiety over time. A significance level of p<0.05 will be applied.
Ethical Considerations:
The study will be conducted following ethical principles. Ethical approval has been or will be obtained from the relevant Institutional Review Board (IRB), and informed consent will be obtained from all participants.
- Conditions
- Yoga Exercises
- Being tested
- Yoga Exercises
- Keywords
- Childbirth trauma, pregnancy, yoga, midwife, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga ExercisesOther
The control and intervention groups received birth preparation training for 45 minutes one day a week for 5 weeks. The experimental group additionally received a total of 10 sessions of a yoga program for 45 minutes, 2 days a week. The content of each yoga session included 10 minutes of mindful breathing, 20 minutes of yoga asanas, and 15 minutes of meditation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group additionally received a total of 10 sessions of a yoga program for 45 minutes, 2 days a week. The content of each yoga session included 10 minutes of mindful breathing, 20 minutes of yoga asanas, and 15 minutes of meditation. Receives: Other: Yoga Exercises |
| control | No intervention | No intervention will be made to the control group. Only measurements will be made on parallel dates with the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pre-test post-test
This study was conducted using the "pre-post test matched group model" to investigate the effects of yoga exercises on the reduction or prevention of childbirth trauma.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Nov 2023
- Primary completion30 Nov 2023
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Yoga ExercisesStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In addition, preliminary information was shared with all potential participants at the beginning of the interviews were given detailed information about the research, and informed consent forms were signed. The control and intervention groups received birth preparation training for 45 minutes one day a week for 5 weeks. The experimental group additionally received a total of 10 sessions of a yoga program for 45 minutes, 2 days a week. The content of each yoga session included 10 minutes of mindful breathing, 20 minutes of yoga asanas, and 15 minutes of meditation. No yoga program was applied to the control group, and psychological assessments were not conducted. tests were performed during the same period as the experimental group. The research data for the experimental and control groups were collected from pregnant women who met the inclusion/exclusion criteria.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Collaborators
- Bartın Unıversity
- Responsible party
- Principal investigator, GÜLESER ADA, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031622
- Sponsor's protocol ID
- BARU-EBE-GA-03
- Status last verified
- Nov 2023
- First submitted
- 4 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yalniz Dilcen H, Ada G, Keskin I, Anderson C. Determining the effect of yoga exercises on psychological health and childbirth trauma in pregnant women: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 Feb 6;26(1):246. doi: 10.1186/s12884-026-08769-z.
PubMed 41652558
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Yoga Exercises on Psychological Health and Childbirth Trauma in Pregnant Women
- ClinicalTrials.gov ID
- NCT07031622
- Acronym / sponsor ID
- BARU-EBE-GA-03
- Conditions
- Yoga Exercises
- Keywords
- Childbirth trauma, pregnancy, yoga, midwife, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Collaborators
- Bartın Unıversity
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 22 Jun 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.
This study aims to investigate the effects of prenatal yoga exercises on psychological health and the perception of traumatic birth in pregnant women. The study will evaluate whether a structured yoga program can reduce anxiety, improve psychological resilience, and decrease the perception of birth-related trauma during pregnancy and postpartum periods.
Study Design:
A pre-post test matched group model will be used to investigate the effects of yoga exercises. The study includes an intervention group receiving prenatal yoga training in addition to standard birth preparation education, and a control group receiving only the birth preparation education.
Population and Sample:
The study will be conducted with pregnant women applying to the obstetrics outpatient clinic of a women's and children's hospital. Eligible participants will be over 18 years of age, over 16 weeks pregnant, have a planned pregnancy, and no diagnosis of high-risk pregnancy. Exclusion criteria include hypertension, gestational diabetes, short cervical length, and low-lying placenta.
A power analysis (Type I error of 0.05, Type II error of 0.20, effect size = 0.80) determined the required sample size as 26 per group, increased to 62 in total to account for potential dropouts.
Detailed description
Title: The Effect of Yoga on Mental Health and Trauma in Pregnant Women
Study Description (Brief Summary):
This study aims to investigate the effects of prenatal yoga exercises on psychological health and the perception of traumatic birth in pregnant women. The study will evaluate whether a structured yoga program can reduce anxiety, improve psychological resilience, and decrease the perception of birth-related trauma during pregnancy and postpartum periods.
Study Design:
A pre-post test matched group model will be used to investigate the effects of yoga exercises. The study includes an intervention group receiving prenatal yoga training in addition to standard birth preparation education, and a control group receiving only the birth preparation education.
Population and Sample:
The study will be conducted with pregnant women applying to the obstetrics outpatient clinic of a women's and children's hospital. Eligible participants will be over 18 years of age, over 16 weeks pregnant, have a planned pregnancy, and no diagnosis of high-risk pregnancy. Exclusion criteria include hypertension, gestational diabetes, short cervical length, and low-lying placenta.
A power analysis (Type I error of 0.05, Type II error of 0.20, effect size = 0.80) determined the required sample size as 26 per group, increased to 62 in total to account for potential dropouts.
Intervention:
The intervention group will attend a 5-week prenatal yoga program comprising 10 sessions (2 sessions/week, 45 minutes/session). Each session includes mindful breathing, yoga asanas, and meditation. Both groups will receive the same standard birth preparation education.
Randomization and Blinding:
Participants will be randomly assigned to intervention and control groups using simple randomization. The study is single-blind: participants will know their group, but intervention implementers and data analysts will be blinded.
Outcome Measures:
Data will be collected using the following tools:
Participant Information Form (demographic and obstetric characteristics)
Brief Psychological Resilience Scale (BPSR)
Traumatic Childbirth Perception Scale (TCPS)
Childbirth Trauma Index Scale (CTIS)
Post-Traumatic Stress Scale - Short Version
State-Trait Anxiety Inventory (STAI)
These scales will be administered pre-intervention, post-intervention, and at 7 and 40 days postpartum.
Data Analysis Plan:
Data will be analyzed using SPSS. Descriptive statistics will summarize demographic and clinical variables. Paired and independent t-tests will compare within and between-group differences. Repeated measures ANOVA will be used to assess changes in trauma perception and anxiety over time. A significance level of p<0.05 will be applied.
Ethical Considerations:
The study will be conducted following ethical principles. Ethical approval has been or will be obtained from the relevant Institutional Review Board (IRB), and informed consent will be obtained from all participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In addition, preliminary information was shared with all potential participants at the beginning of the interviews were given detailed information about the research, and informed consent forms were signed. The control and intervention groups received birth preparation training for 45 minutes one day a week for 5 weeks. The experimental group additionally received a total of 10 sessions of a yoga program for 45 minutes, 2 days a week. The content of each yoga session included 10 minutes of mindful breathing, 20 minutes of yoga asanas, and 15 minutes of meditation. No yoga program was applied to the control group, and psychological assessments were not conducted. tests were performed during the same period as the experimental group. The research data for the experimental and control groups were collected from pregnant women who met the inclusion/exclusion criteria.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Yoga ExercisesThe experimental group additionally received a total of 10 sessions of a yoga program for 45 minutes, 2 days a week. The content of each yoga session included 10 minutes of mindful breathing, 20 minutes of yoga asanas, and 15 minutes of meditation. |
| control | No intervention | –No intervention will be made to the control group. Only measurements will be made on parallel dates with the experimental group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Over 18 years old
- Over 16 weeks
- Without a diagnosis of high-risk pregnancy
- Not exercising before pregnancy
- Planned pregnancy
Key exclusion criteria (4 listed)
- Hypertension
- Gestational diabetes
- Short cervical length
- Low-lying placenta
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 |
|---|---|---|
| Yoga ExercisesThe control and intervention groups received birth preparation training for 45 minutes one day a week for 5 weeks. The experimental group additionally received a total of 10 sessions of a yoga program for 45 minutes, 2 days a week. The content of each yoga session included 10 minutes of mindful breathing, 20 minutes of yoga asanas, and 15 minutes of meditation. | Other | Experimental group |
Primary outcome
pre-test post-test
Time frame: 1 year
This study was conducted using the "pre-post test matched group model" to investigate the effects of yoga exercises on the reduction or prevention of childbirth trauma.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Derived from this study: PubMed 41652558Yalniz Dilcen H, Ada G, Keskin I, Anderson C. Determining the effect of yoga exercises on psychological health and childbirth trauma in pregnant women: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 Feb 6;26(1):246. doi: 10.1186/s12884-026-08769-z.
- Individual participant dataSharing planned: No
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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 Exercises in people with Yoga Exercises, run by Sakarya 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pre-test post-test (time frame: 1 year). 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 NCT07031622, which also lists 1 linked publication.
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 22 Jun 2025.