Prenatal YogaNCT07489781
Mindfulness-Based Childbirth and Parenting Intervention and Prenatal Yoga on Birth Self-Efficacy, Fear of Childbirth, and Preferred Mode of Delivery in Primigravid Women
A study testing Prenatal yoga and Mindfulness-Based Childbirth in people with Prenatal Yoga and Mindfulness-Based Childbirth, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
(a) This thesis aims to examine the effects of counseling and prenatal yoga implemented within the scope of the Mindfulness-Based Childbirth and Parenting (MBCP) model on birth self-efficacy, fear of childbirth, and birth mode preferences among primigravid women. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prenatal Yoga, Mindfulness-Based Childbirth, Parenting Counseling
- What is being tested?
- Prenatal yoga and Mindfulness-Based Childbirth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2026to 6 Dec 2026
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteered to participate in the study,
- Were between 18 and 45 years of age,
- Were literate,
- Were between 22 and 28 weeks of gestation,
- Were primigravid,
- Had a singleton viable pregnancy,
Show all 9Show fewer
- Were able to use a mobile phone or computer,
- Scored ≤12 on the Edinburgh Postnatal Depression Scale (EPDS),
- Had not previously received prenatal yoga training.
Who cannot join
- Conceived through assisted reproductive techniques (ART),
- Had a high-risk pregnancy,
- Were multiparous,
- Had a diagnosed psychiatric disorder or were receiving psychiatric treatment (as reported by the patient and/or physician),
- Had a mental condition such as intellectual disability or dementia that could interfere with cooperation (as reported by the patient and/or physician),
- Were currently participating in any individual or group psychotherapy or counseling program,
- Had visual or hearing impairments that could hinder communication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of a Mindfulness-Based Childbirth and Parenting Intervention and Prenatal Yoga on Birth Self-Efficacy, Fear of Childbirth, and Preferred Mode of Delivery in Primigravid Women
(a) This thesis aims to examine the effects of counseling and prenatal yoga implemented within the scope of the Mindfulness-Based Childbirth and Parenting (MBCP) model on birth self-efficacy, fear of childbirth, and birth mode preferences among primigravid women. The planned study is expected to support the existing literature and constitutes an original contribution by addressing women's health from a holistic perspective.
(b) This prospective randomized controlled study is planned to be conducted face-to-face between January 2026 and February 2027 at Medipol Ankara Hospital and Hacettepe University with a total of n = 164 pregnant women who volunteer to participate in the study and have no previous birth experience (control: 41; intervention-1 [counseling based on the MBCP model]: 41; intervention-2 [prenatal yoga]: 41; intervention-3 [combined MBCP-based counseling and prenatal yoga]: 41).
Read more
Within the scope of the study, an 8-week intervention program including MBCP-based counseling and prenatal yoga will be implemented. Data will be collected using the Introductory Information Form developed in line with the literature, the Edinburgh Postnatal Depression Scale, the Personal Information Form, the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ A), the Childbirth Self-Efficacy Inventory Short Form, the Fear of Childbirth Scale, and the Birth Mode Preference Scale.
The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki, and the CONSORT checklist will be followed during the reporting process.
(c) The thesis will be carried out by a doctoral student in the thesis phase and their advisor at the Department of Nursing, Institute of Health Sciences, Eskişehir Osmangazi University.
(d) The findings of this thesis are expected to provide comprehensive evidence regarding the effects of MBCP-based counseling and prenatal yoga interventions on birth self-efficacy, fear of childbirth, and birth mode preferences among pregnant women. Furthermore, the results are anticipated to contribute significantly to academic, social, healthcare, and economic domains, and to support the strengthening of woman-centered care approaches in maternity services.
- Being tested
- Prenatal yoga, Mindfulness-Based Childbirth
- Keywords
- Birth Self-Efficacy, Fear of Childbirth, Delivery Mode, Primigravid Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal yogaOther
Each group will consist of five (5) participants; however, due to the sample size, the final group will include six (6) participants. The prenatal yoga program is structured to last a total of eight weeks and will be conducted as two (2) sessions per week. Each session is planned to last approximately 75-90 minutes. The first 30 minutes of each session will consist of core prenatal yoga practices that will be applied consistently throughout all weeks. The remaining 45-60 minutes will include session components specifically structured for each week. The core components of the prenatal yoga program and the weekly session contents are presented in separate tables below to ensure standardization of the intervention and to enhance its reproducibility.
Mindfulness-Based ChildbirthOther
Each group will consist of five (5) participants; however, due to the sample size, the final group will include six (6) participants. The Mindfulness-Based Childbirth and Parenting (MBCP) program is structured to last a total of eight weeks and will be conducted as two (2) sessions per week. Each session is planned to last approximately 60 minutes. The program will be implemented through core practices of the Mindfulness-Based Childbirth and Parenting model, along with session contents specifically structured for each week.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Mindfulness-Based Childbirth | Experimental | Not described Receives: Other: Mindfulness-Based Childbirth |
| Prenatal yoga | Experimental | Not described Receives: Other: Prenatal yoga |
| Mindfulness-Based Childbirth and prenatal yoga | Experimental | Not described Receives: Other: Prenatal yoga; Other: Mindfulness-Based Childbirth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childbirth Self-Efficacy Inventory - Short Form (CBSEI-SF)
Scores obtained from each subscale range between 16 and 160, while the total score ranges from 32 to 320. Higher scores indicate higher levels of childbirth self-efficacy and more positive outcome expectations. The scale is rated on a 10-point Likert scale. In the outcome expectancy subscale, responses range from 1 ("not at all helpful") to 10 ("very helpful"). In the efficacy expectancy subscale, items 1-13 are scored from 1 ("completely sure") to 10 ("not at all sure"), whereas the remaining items are scored from 1 ("not at all sure") to 10 ("completely sure"). The first 13 items of the efficacy expectancy subscale are reverse-coded.
Measured: change from before implamentation patent and after 4st, and 8th week of practice
Fear of Childbirth Scale (FOCS)
The Fear of Childbirth Scale consists of 10 items. Participants are asked to rate each item on a scale from 1 ("strongly disagree") to 10 ("strongly agree"). Five items (items 1, 3, 5, 7, and 10) are positively worded, and five items (items 2, 4, 6, 8, and 9) are negatively worded. The positively worded items are reverse-coded.
Measured: change from before implamentation patent and after 4st, and 8th week of practice
Pregnant Women's Birth Mode Preference Scale
The scale consists of 18 items and three subscales: self-efficacy, normative beliefs, and preferences. It is rated on a 5-point Likert scale. Higher scores indicate stronger tendencies and attitudes within the subscales. This scale is a valid and reliable instrument for assessing psychosocial factors influencing pregnant women's preferences regarding mode of delivery.
Measured: change from before implamentation patent and after 4st, and 8th week of practice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start6 Jan 2026
- Primary completion6 Mar 2026
- Study completion6 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal YogaStudies 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
- Model description
- This thesis was designed as a prospective randomized controlled study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu KUCUKKAYA, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489781
- Sponsor's protocol ID
- 2025-SBB-0951
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Mindfulness-Based Childbirth and Parenting Intervention and Prenatal Yoga on Birth Self-Efficacy, Fear of Childbirth, and Preferred Mode of Delivery in Primigravid Women
- ClinicalTrials.gov ID
- NCT07489781
- Acronym / sponsor ID
- 2025-SBB-0951
- Keywords
- Birth Self-Efficacy, Fear of Childbirth, Delivery Mode, Primigravid Women
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- 6 Dec 2026 (estimated)
- First posted
- 24 Mar 2026 (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.
(a) This thesis aims to examine the effects of counseling and prenatal yoga implemented within the scope of the Mindfulness-Based Childbirth and Parenting (MBCP) model on birth self-efficacy, fear of childbirth, and birth mode preferences among primigravid women. The planned study is expected to support the existing literature and constitutes an original contribution by addressing women's health from a holistic perspective.
(b) This prospective randomized controlled study is planned to be conducted face-to-face between January 2026 and February 2027 at Medipol Ankara Hospital and Hacettepe University with a total of n = 164 pregnant women who volunteer to participate in the study and have no previous birth experience (control: 41; intervention-1 [counseling based on the MBCP model]: 41; intervention-2 [prenatal yoga]: 41; intervention-3 [combined MBCP-based counseling and prenatal yoga]: 41).
Within the scope of the study, an 8-week intervention program including MBCP-based counseling and prenatal yoga will be implemented. Data will be collected using the Introductory Information Form developed in line with the literature, the Edinburgh Postnatal Depression Scale, the Personal Information Form, the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ A), the Childbirth Self-Efficacy Inventory Short Form, the Fear of Childbirth Scale, and the Birth Mode Preference Scale.
The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki, and the CONSORT checklist will be followed during the reporting process.
(c) The thesis will be carried out by a doctoral student in the thesis phase and their advisor at the Department of Nursing, Institute of Health Sciences, Eskişehir Osmangazi University.
(d) The findings of this thesis are expected to provide comprehensive evidence regarding the effects of MBCP-based counseling and prenatal yoga interventions on birth self-efficacy, fear of childbirth, and birth mode preferences among pregnant women. Furthermore, the results are anticipated to contribute significantly to academic, social, healthcare, and economic domains, and to support the strengthening of woman-centered care approaches in maternity services.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This thesis was designed as a prospective randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Mindfulness-Based Childbirth | Experimental | Other: Mindfulness-Based Childbirth |
| Prenatal yoga | Experimental | Other: Prenatal yoga |
| Mindfulness-Based Childbirth and prenatal yoga | Experimental | Other: Prenatal yoga, Other: Mindfulness-Based Childbirth |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Volunteered to participate in the study,
- Were between 18 and 45 years of age,
- Were literate,
- Were between 22 and 28 weeks of gestation,
- Were primigravid,
Key exclusion criteria (7 listed)
- Conceived through assisted reproductive techniques (ART),
- Had a high-risk pregnancy,
- Were multiparous,
- Had a diagnosed psychiatric disorder or were receiving psychiatric treatment (as reported by the patient and/or physician),
- Had a mental condition such as intellectual disability or dementia that could interfere with cooperation (as reported by the patient and/or physician),
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 |
|---|---|---|
| Prenatal yogaEach group will consist of five (5) participants; however, due to the sample size, the final group will include six (6) participants. The prenatal yoga program is structured to last a total of eight weeks and will be conducted as two (2) sessions per week. Each session is planned to last approximately 75-90 minutes. The first 30 minutes of each session will consist of core prenatal yoga practices that will be applied consistently throughout all weeks. The remaining 45-60 minutes will include session components specifically structured for each week. The core components of the prenatal yoga program and the weekly session contents are presented in separate tables below to ensure standardization of the intervention and to enhance its reproducibility. | Other | Mindfulness-Based Childbirth and prenatal yoga, Prenatal yoga |
| Mindfulness-Based ChildbirthEach group will consist of five (5) participants; however, due to the sample size, the final group will include six (6) participants. The Mindfulness-Based Childbirth and Parenting (MBCP) program is structured to last a total of eight weeks and will be conducted as two (2) sessions per week. Each session is planned to last approximately 60 minutes. The program will be implemented through core practices of the Mindfulness-Based Childbirth and Parenting model, along with session contents specifically structured for each week. | Other | Mindfulness-Based Childbirth, Mindfulness-Based Childbirth and prenatal yoga |
Primary outcome
Childbirth Self-Efficacy Inventory - Short Form (CBSEI-SF)
Time frame: change from before implamentation patent and after 4st, and 8th week of practice
Scores obtained from each subscale range between 16 and 160, while the total score ranges from 32 to 320. Higher scores indicate higher levels of childbirth self-efficacy and more positive outcome expectations. The scale is rated on a 10-point Likert scale. In the outcome expectancy subscale, responses range from 1 ("not at all helpful") to 10 ("very helpful"). In the efficacy expectancy subscale, items 1-13 are scored from 1 ("completely sure") to 10 ("not at all sure"), whereas the remaining items are scored from 1 ("not at all sure") to 10 ("completely sure"). The first 13 items of the efficacy expectancy subscale are reverse-coded.
Fear of Childbirth Scale (FOCS)
Time frame: change from before implamentation patent and after 4st, and 8th week of practice
The Fear of Childbirth Scale consists of 10 items. Participants are asked to rate each item on a scale from 1 ("strongly disagree") to 10 ("strongly agree"). Five items (items 1, 3, 5, 7, and 10) are positively worded, and five items (items 2, 4, 6, 8, and 9) are negatively worded. The positively worded items are reverse-coded.
Pregnant Women's Birth Mode Preference Scale
Time frame: change from before implamentation patent and after 4st, and 8th week of practice
The scale consists of 18 items and three subscales: self-efficacy, normative beliefs, and preferences. It is rated on a 5-point Likert scale. Higher scores indicate stronger tendencies and attitudes within the subscales. This scale is a valid and reliable instrument for assessing psychosocial factors influencing pregnant women's preferences regarding mode of delivery.
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 24 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Prenatal Care
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 Prenatal yoga and Mindfulness-Based Childbirth in people with Prenatal Yoga and Mindfulness-Based Childbirth, run by Trakya 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 9 inclusion and 7 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 24 Mar 2026. 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?
Childbirth Self-Efficacy Inventory - Short Form (CBSEI-SF) (time frame: change from before implamentation patent and after 4st, and 8th week of practice). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2026.