Pregnancy in AdolescenceNCT07540923
Effect of MBSR Training on Childbirth Fear, Bonding and Breastfeeding in Adolescent Pregnant Women
A study testing Mindfulness-Based Stress Reduction (MBSR) Training in people with Pregnancy in Adolescence and Fear, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to evaluate the effect of Mindfulness-Based Stress Reduction (MBSR) training given to adolescent pregnant women and their partners on fear of childbirth, maternal and paternal bonding, and breastfeeding success. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy in Adolescence, Fear, Mother-Child Relations
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR) Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 30 May 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 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Being between 15-19 years of age
- Being in the third trimester of pregnancy (30-33 weeks of gestation)
- Being primiparous
- Having no history of miscarriage, abortion or similar obstetric problems during pregnancy
- Not having a high-risk pregnancy diagnosis
- Being literate
- Partner accepting to actively participate in the parenting process
Who cannot join
- Having a chronic disease
- Having physical or psychological health problems
- Having a psychiatric diagnosis in the participant or their partner
- Having a detected health problem or congenital anomaly in the fetus
- Having previously received Mindfulness-Based Stress Reduction (MBSR) training
- Not completing the planned training program
- Voluntarily withdrawing from the study
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, 1 recruiting
- Recruiting
Inonu University Faculty of Medicine
Malatya, Malatya, 44280
Hacer ÜNVER KOCA, PhD, 05446799899, hacer.unver@inonu.edu.tr
Nilay FİLOĞLU, MSc, 05303089717, nilayfiloglu@artuklu.edu.tr
About this study
Official title: Effect of Mindfulness-Based Stress Reduction Training on Fear of Childbirth, Maternal and Paternal Bonding and Breastfeeding Success in Adolescent Pregnant Women and Their Partners
This randomized controlled study aims to evaluate the effect of Mindfulness-Based Stress Reduction (MBSR) training given to adolescent pregnant women and their partners on fear of childbirth, maternal and paternal bonding, and breastfeeding success. Adolescent pregnancy is associated with increased stress, fear of childbirth and parenting anxiety, which negatively affect mother-infant and father-infant bonding and breastfeeding outcomes. MBSR training is expected to reduce fear of childbirth, strengthen maternal and paternal bonding, and improve breastfeeding success in adolescent pregnant women and their partners compared to the control group receiving routine care.
Read the detailed description
This randomized controlled study aims to evaluate the effect of Mindfulness-Based Stress Reduction (MBSR) training given to adolescent pregnant women and their partners on fear of childbirth, maternal and paternal bonding, and breastfeeding success. Adolescent pregnancy is associated with increased stress, fear of childbirth and parenting anxiety, which negatively affect mother-infant and father-infant bonding and breastfeeding outcomes. MBSR training is expected to reduce fear of childbirth, strengthen maternal and paternal bonding, and improve breastfeeding success in adolescent pregnant women and their partners compared to the control group receiving routine care.
- Being tested
- Mindfulness-Based Stress Reduction (MBSR) Training
- Keywords
- Adolescent Pregnancy, Fear of Childbirth, Maternal Bonding, Paternal Bonding, Mindfulness-Based Stress Reduction, Breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR) TrainingBehavioural
Also called MBSR
Mindfulness-Based Stress Reduction (MBSR) training program delivered to adolescent pregnant women and their partners. The program consists of 8 sessions in total, conducted twice a week for 4 weeks. Each session lasts approximately 40 minutes and includes mindfulness meditation, breathing exercises, body scan and stress management techniques. The training aims to reduce fear of childbirth, strengthen maternal and paternal bonding, and improve breastfeeding success.
| Study group | Role | What they receive |
|---|---|---|
| MBSR Training Group | Experimental | Adolescent pregnant women and their partners receiving Mindfulness-Based Stress Reduction (MBSR) training in addition to routine care. Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) Training |
| Control Group | No intervention | Adolescent pregnant women and their partners receiving only routine care without any additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Childbirth
Fear of childbirth will be measured using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A) in adolescent pregnant women and their partners. Scores range from 0 to 165, with higher scores indicating greater fear of childbirth.
Measured: Baseline and 4 weeks after the intervention
Secondary outcomes (1)
Maternal Bonding
Maternal bonding will be assessed using the Maternal Attachment Scale. Scores range from 26 to 104, with higher scores indicating stronger maternal attachment.
Measured: Baseline and 4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Dec 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy in AdolescenceStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Unver, PhD, Inonu University
- Investigators
- Hacer ÜNVER KOCA, PhD, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540923
- Sponsor's protocol ID
- 2025/2-17
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindfulness-Based Stress Reduction Training on Fear of Childbirth, Maternal and Paternal Bonding and Breastfeeding Success in Adolescent Pregnant Women and Their Partners
- ClinicalTrials.gov ID
- NCT07540923
- Acronym / sponsor ID
- 2025/2-17
- Keywords
- Adolescent Pregnancy, Fear of Childbirth, Maternal Bonding, Paternal Bonding, Mindfulness-Based Stress Reduction, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 21 Apr 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 study aims to evaluate the effect of Mindfulness-Based Stress Reduction (MBSR) training given to adolescent pregnant women and their partners on fear of childbirth, maternal and paternal bonding, and breastfeeding success. Adolescent pregnancy is associated with increased stress, fear of childbirth and parenting anxiety, which negatively affect mother-infant and father-infant bonding and breastfeeding outcomes. MBSR training is expected to reduce fear of childbirth, strengthen maternal and paternal bonding, and improve breastfeeding success in adolescent pregnant women and their partners compared to the control group receiving routine care.
Detailed description
This randomized controlled study aims to evaluate the effect of Mindfulness-Based Stress Reduction (MBSR) training given to adolescent pregnant women and their partners on fear of childbirth, maternal and paternal bonding, and breastfeeding success. Adolescent pregnancy is associated with increased stress, fear of childbirth and parenting anxiety, which negatively affect mother-infant and father-infant bonding and breastfeeding outcomes. MBSR training is expected to reduce fear of childbirth, strengthen maternal and paternal bonding, and improve breastfeeding success in adolescent pregnant women and their partners compared to the control group receiving routine care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBSR Training Group | Experimental | Behavioral: Mindfulness-Based Stress Reduction (MBSR) TrainingAdolescent pregnant women and their partners receiving Mindfulness-Based Stress Reduction (MBSR) training in addition to routine care. |
| Control Group | No intervention | –Adolescent pregnant women and their partners receiving only routine care without any additional intervention. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Being between 15-19 years of age
- Being in the third trimester of pregnancy (30-33 weeks of gestation)
- Being primiparous
- Having no history of miscarriage, abortion or similar obstetric problems during pregnancy
- Not having a high-risk pregnancy diagnosis
Key exclusion criteria (7 listed)
- Having a chronic disease
- Having physical or psychological health problems
- Having a psychiatric diagnosis in the participant or their partner
- Having a detected health problem or congenital anomaly in the fetus
- Having previously received Mindfulness-Based Stress Reduction (MBSR) training
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 Stress Reduction (MBSR) TrainingAlso: MBSRMindfulness-Based Stress Reduction (MBSR) training program delivered to adolescent pregnant women and their partners. The program consists of 8 sessions in total, conducted twice a week for 4 weeks. Each session lasts approximately 40 minutes and includes mindfulness meditation, breathing exercises, body scan and stress management techniques. The training aims to reduce fear of childbirth, strengthen maternal and paternal bonding, and improve breastfeeding success. | Behavioural | MBSR Training Group |
Primary outcome
Fear of Childbirth
Time frame: Baseline and 4 weeks after the intervention
Fear of childbirth will be measured using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A) in adolescent pregnant women and their partners. Scores range from 0 to 165, with higher scores indicating greater fear of childbirth.
1 secondary outcome
Maternal Bonding
Time frame: Baseline and 4 weeks after the intervention
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 21 Apr 2026.
- 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.
Hacer ÜNVER KOCA, PhD principal investigator
Inonu University
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 Stress Reduction (MBSR) Training in people with Pregnancy in Adolescence and Fear, run by Inonu 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 7 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: looking for participants now, as of the sponsor's last update on 21 Apr 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 Hacer ÜNVER KOCA, PhD (0544 679 98 99, hacer.unver@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Childbirth (time frame: Baseline and 4 weeks after the intervention). 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 21 Apr 2026.