NCT07647211

Brief Summary

This randomized controlled trial aims to evaluate the effect of a mindfulness-based breastfeeding education program on breastfeeding outcomes among mothers who are not exclusively breastfeeding. Participants will be randomly assigned to either the intervention or control group. The intervention group will receive a mindfulness-based breastfeeding education program in addition to routine care. Breastfeeding outcomes, maternal breastfeeding self-efficacy, and related variables will be assessed following the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

May 14, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

breastfeedingmidwifemindfulnessself-efficacy

Outcome Measures

Primary Outcomes (1)

  • Mindful Breastfeeding Scale

    This is a 9-item measurement tool designed to assess awareness-based breastfeeding practices during the postpartum period. The scale is unidimensional and was developed using a 5-point Likert scale. Responses to the scale items range from "always" to "never." The total score on the scale ranges from 9 to 45, and as the total score increases, the level of awareness regarding breastfeeding also increases.

    Baseline, 4th week postpartum, 4th month postpartum

Study Arms (2)

Mindfulness-Based Breastfeeding Education Group

EXPERIMENTAL

Participants received a 4-week mindfulness-based breastfeeding education program consisting of two individual sessions per week (50-60 minutes each) delivered by a trained midwife. The program combined breastfeeding education with mindfulness-based stress reduction techniques (breathing meditation, body scan, sitting meditation, mountain meditation, and loving-kindness meditation). Practical breastfeeding training was supported using a doll and breast model. Participants also received audio-guided mindfulness exercises and a mindful movement/yoga video for daily home practice, in addition to routine postpartum care.

Behavioral: Mindfulness-Based Breastfeeding Education Group

Control Group

NO INTERVENTION

Participants received routine postpartum follow-up and standard breastfeeding counseling provided at Family Health Centres. No additional mindfulness-based intervention was administered. Counseling included brief education and support related to breastfeeding as part of standard care.

Interventions

A 4-week mindfulness-based breastfeeding education program was implemented, consisting of two individual sessions per week (50-60 minutes each) delivered by a trained midwife. The intervention combined breastfeeding education with mindfulness-based stress reduction techniques, including breathing meditation, body scan meditation, sitting meditation, mountain meditation, and loving-kindness (Metta) meditation. Practical breastfeeding training was provided using a doll and breast model to support skill acquisition. Participants were also given audio-guided mindfulness exercises and a mindful movement/yoga video for daily home practice in addition to routine postpartum care.

Also known as: mindful breastfeeding group
Mindfulness-Based Breastfeeding Education Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly postpartum women are eligible to participate in the study.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years of age or older, being in the first month postpartum, having a full-term, singleton, and healthy infant, and not exclusively breastfeeding the infant (i.e., using formula or other foods in addition to breast milk)

You may not qualify if:

  • Having previously received mindfulness or similar training, having a diagnosed psychiatric disorder, and having any condition that impairs communication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Health Centres (FHCs) in the provincial centre of Elazığ, Türkiye

Elâzığ, 23100, Turkey (Türkiye)

Location

Related Publications (1)

  • Kurt N, Uçar T, Effect of mindfulness-based breastfeeding education on breastfeeding outcomes: a randomized controlled trial. Manuscript in preparation.

    RESULT

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 14, 2026

First Posted

June 15, 2026

Study Start

October 31, 2023

Primary Completion

April 15, 2025

Study Completion

July 14, 2025

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

IPD will not be shared to protect participant confidentiality and in accordance with ethical approval and informed consent restrictions.

Locations