NCT07540923

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Dec 2025May 2026

Study Start

First participant enrolled

December 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 7, 2026

Last Update Submit

April 17, 2026

Conditions

Keywords

Adolescent PregnancyFear of ChildbirthMaternal BondingPaternal BondingMindfulness-Based Stress ReductionBreastfeeding

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 4 weeks after the intervention

Secondary Outcomes (1)

  • Maternal Bonding

    Baseline and 4 weeks after the intervention

Other Outcomes (2)

  • Paternal Bonding

    Baseline and 4 weeks after the intervention

  • Breastfeeding Success

    t postpartum 24-48 hours

Study Arms (2)

MBSR Training Group

EXPERIMENTAL

Adolescent pregnant women and their partners receiving Mindfulness-Based Stress Reduction (MBSR) training in addition to routine care.

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.

Interventions

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.

Also known as: MBSR
MBSR Training Group

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University Faculty of Medicine

Malatya, Malatya, 44280, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Hacer ÜNVER KOCA, PhD

    Inonu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hacer ÜNVER KOCA, PhD

CONTACT

Nilay FİLOĞLU, MsC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 21, 2026

Study Start

December 1, 2025

Primary Completion

April 30, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations