PregnancyMBCPNCT07660471
Mindfulness-Based Intervention in Primiparous Pregnant Women
A study testing Mindfulness-Based Intervention in people with Pregnancy and Fear of Childbirth, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of a mindfulness-based intervention on childbirth self-efficacy, fear of childbirth, and self-compassion among primiparous pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Fear of Childbirth, Childbirth Self-efficacy
- What is being tested?
- Mindfulness-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 31 Oct 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women aged 18 years and older
- Primiparous women
- Singleton pregnancy
- Gestational age between 28 and 32 weeks
- No known obstetric complications
- Ability to read and understand Turkish
Show all 9Show fewer
- Attendance at the Pregnancy School of the Healthy Life Center
- Willingness to participate and provide written informed consent
- Willingness to participate in the mindfulness-based intervention program
Who cannot join
- Multiple pregnancy
- High-risk obstetric complications (e.g., preeclampsia, gestational diabetes, placenta previa)
- Diagnosed severe psychiatric disorders (e.g., psychotic disorders, bipolar disorder)
- Substance or alcohol dependence
- Previous participation in a structured mindfulness, meditation, or similar awareness-based program
- Inability to attend intervention sessions regularly
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Healthy Life Center Pregnancy School
Ağrı
Ebru Solmaz, PhD, +905377737260, esolmaz@agri.edu.tr
About this study
Official title: Effect of a Mindfulness-Based Intervention on Childbirth Self-Efficacy, Fear of Childbirth, and Self-Compassion in Primiparous Pregnant Women: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effect of a mindfulness-based intervention on childbirth self-efficacy, fear of childbirth, and self-compassion among primiparous pregnant women. Eligible pregnant women will be randomly assigned to either a mindfulness intervention group or a control group receiving routine antenatal education and standard prenatal care. The intervention program will consist of eight sessions delivered over four weeks. Outcomes will be assessed before and after the intervention using validated measurement tools. The findings may contribute to the development of effective psychosocial interventions to improve maternal well-being during pregnancy.
Read the detailed description
Pregnancy is a period characterized by significant physical, psychological, and social changes. Fear of childbirth, low childbirth self-efficacy, and difficulties in self-compassion may negatively affect maternal well-being and childbirth experiences. Mindfulness-based interventions have been increasingly used to support psychological health during pregnancy; however, evidence regarding their effects on childbirth self-efficacy, fear of childbirth, and self-compassion remains limited.
This study is designed as a randomized controlled trial to evaluate the effectiveness of a mindfulness-based intervention among primiparous pregnant women attending a pregnancy school affiliated with a Healthy Life Center in Ağrı, Türkiye. A total of 128 eligible pregnant women will be randomly assigned to either an intervention group or a control group.
Participants in the intervention group will receive a four-week mindfulness-based intervention consisting of eight sessions focused on breathing awareness, body awareness, emotional awareness, non-judgmental acceptance, self-compassion, and mindfulness-based coping strategies for childbirth preparation. Participants in the control group will continue to receive routine antenatal education and standard prenatal care.
Data will be collected before and after the intervention using validated instruments assessing childbirth self-efficacy, fear of childbirth, and self-compassion. The results of this study may provide evidence for the integration of mindfulness-based approaches into antenatal care programs to enhance maternal psychological well-being and preparedness for childbirth.
- Being tested
- Mindfulness-Based Intervention
- Keywords
- Mindfulness, Mindfulness-Based Intervention, Pregnancy, Primiparous Pregnant Women, Fear of Childbirth, Childbirth Self-Efficacy, Self-Compassion, Maternal Mental Health, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based InterventionBehavioural
A four-week mindfulness-based intervention consisting of eight sessions delivered twice weekly. The program includes breathing awareness, body awareness, emotional awareness, non-judgmental acceptance, self-compassion practices, and mindfulness-based coping strategies for childbirth preparation. Sessions will be delivered face-to-face and will last approximately 60-90 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Intervention Group | Experimental | Participants in this group will receive a four-week mindfulness-based intervention consisting of eight sessions focused on breathing awareness, body awareness, emotional awareness, self-compassion, and mindfulness-based coping strategies for childbirth preparation. Receives: Behavioral: Mindfulness-Based Intervention |
| Routine Antenatal Care Group | No intervention | Participants will receive routine antenatal education and standard prenatal care. No mindfulness-based intervention will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childbirth Self-Efficacy
Assessment of childbirth self-efficacy using the Childbirth Self-Efficacy Scale.
Measured: Baseline and 4 weeks after intervention
Fear of Childbirth
Assessment of fear of childbirth using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A).
Measured: Baseline and 4 weeks after intervention
Self-Compassion
Assessment of self-compassion using the Self-Compassion Scale.
Measured: Baseline and 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
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 PregnancyStudies 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
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive a four-week mindfulness-based intervention consisting of eight sessions, while the control group will continue to receive routine antenatal education and standard prenatal care. Outcome measures will be assessed at baseline and after completion of the intervention.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru SOLMAZ, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660471
- Sponsor's protocol ID
- PMI-2026-01
- Acronym
- MBCP
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available in order to protect participant confidentiality and privacy. Only de-identified aggregate study results will be reported.
Publications
Feli R, Heydarpour S, Yazdanbakhsh K, Heydarpour F. The effect of mindfulness-based counselling on the anxiety levels and childbirth satisfaction among primiparous pregnant women: a randomized controlled trial. BMC Psychiatry. 2024 Dec 31;24(1):964. doi: 10.1186/s12888-024-06442-3.
PubMed 39741245
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Mindfulness-Based Intervention on Childbirth Self-Efficacy, Fear of Childbirth, and Self-Compassion in Primiparous Pregnant Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07660471
- Acronym / sponsor ID
- MBCP / PMI-2026-01
- Keywords
- Mindfulness, Mindfulness-Based Intervention, Pregnancy, Primiparous Pregnant Women, Fear of Childbirth, Childbirth Self-Efficacy, Self-Compassion, Maternal Mental Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 22 Jun 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.
This randomized controlled trial aims to evaluate the effect of a mindfulness-based intervention on childbirth self-efficacy, fear of childbirth, and self-compassion among primiparous pregnant women. Eligible pregnant women will be randomly assigned to either a mindfulness intervention group or a control group receiving routine antenatal education and standard prenatal care. The intervention program will consist of eight sessions delivered over four weeks. Outcomes will be assessed before and after the intervention using validated measurement tools. The findings may contribute to the development of effective psychosocial interventions to improve maternal well-being during pregnancy.
Detailed description
Pregnancy is a period characterized by significant physical, psychological, and social changes. Fear of childbirth, low childbirth self-efficacy, and difficulties in self-compassion may negatively affect maternal well-being and childbirth experiences. Mindfulness-based interventions have been increasingly used to support psychological health during pregnancy; however, evidence regarding their effects on childbirth self-efficacy, fear of childbirth, and self-compassion remains limited.
This study is designed as a randomized controlled trial to evaluate the effectiveness of a mindfulness-based intervention among primiparous pregnant women attending a pregnancy school affiliated with a Healthy Life Center in Ağrı, Türkiye. A total of 128 eligible pregnant women will be randomly assigned to either an intervention group or a control group.
Participants in the intervention group will receive a four-week mindfulness-based intervention consisting of eight sessions focused on breathing awareness, body awareness, emotional awareness, non-judgmental acceptance, self-compassion, and mindfulness-based coping strategies for childbirth preparation. Participants in the control group will continue to receive routine antenatal education and standard prenatal care.
Data will be collected before and after the intervention using validated instruments assessing childbirth self-efficacy, fear of childbirth, and self-compassion. The results of this study may provide evidence for the integration of mindfulness-based approaches into antenatal care programs to enhance maternal psychological well-being and preparedness for childbirth.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups. The intervention group will receive a four-week mindfulness-based intervention consisting of eight sessions, while the control group will continue to receive routine antenatal education and standard prenatal care. Outcome measures will be assessed at baseline and after completion of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Intervention Group | Experimental | Behavioral: Mindfulness-Based InterventionParticipants in this group will receive a four-week mindfulness-based intervention consisting of eight sessions focused on breathing awareness, body awareness, emotional awareness, self-compassion, and mindfulness-based coping strategies for childbirth preparation. |
| Routine Antenatal Care Group | No intervention | –Participants will receive routine antenatal education and standard prenatal care. No mindfulness-based intervention will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pregnant women aged 18 years and older
- Primiparous women
- Singleton pregnancy
- Gestational age between 28 and 32 weeks
- No known obstetric complications
Key exclusion criteria (6 listed)
- Multiple pregnancy
- High-risk obstetric complications (e.g., preeclampsia, gestational diabetes, placenta previa)
- Diagnosed severe psychiatric disorders (e.g., psychotic disorders, bipolar disorder)
- Substance or alcohol dependence
- Previous participation in a structured mindfulness, meditation, or similar awareness-based program
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 |
|---|---|---|
| Mindfulness-Based InterventionA four-week mindfulness-based intervention consisting of eight sessions delivered twice weekly. The program includes breathing awareness, body awareness, emotional awareness, non-judgmental acceptance, self-compassion practices, and mindfulness-based coping strategies for childbirth preparation. Sessions will be delivered face-to-face and will last approximately 60-90 minutes each. | Behavioural | Mindfulness-Based Intervention Group |
Primary outcome
Childbirth Self-Efficacy
Time frame: Baseline and 4 weeks after intervention
Assessment of childbirth self-efficacy using the Childbirth Self-Efficacy Scale.
Fear of Childbirth
Time frame: Baseline and 4 weeks after intervention
Assessment of fear of childbirth using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A).
Self-Compassion
Time frame: Baseline and 4 weeks after intervention
Assessment of self-compassion using the Self-Compassion Scale.
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 22 Jun 2026.
- Results publication: PubMed 39741245Feli R, Heydarpour S, Yazdanbakhsh K, Heydarpour F. The effect of mindfulness-based counselling on the anxiety levels and childbirth satisfaction among primiparous pregnant women: a randomized controlled trial. BMC Psychiatry. 2024 Dec 31;24(1):964. doi: 10.1186/s12888-024-06442-3.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly available in order to protect participant confidentiality and privacy. Only de-identified aggregate study results will be reported.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Intervention in people with Pregnancy and Fear of Childbirth, run by Agri Ibrahim Cecen 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 6 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: opening soon, as of the sponsor's last update on 22 Jun 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?
Contact Ebru Solmaz, PhD (+905377737260, esolmaz@agri.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childbirth Self-Efficacy (time frame: Baseline and 4 weeks after intervention). 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?
On the ClinicalTrials.gov record for NCT07660471, 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 2026.