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Completed

NCT Number: NCT07647211

MINDFULNESS-BASED BREASTFEEDING EDUCATION PROGRAM

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Elâzığ, 23100, Turkey (Türkiye)

About this study

Breastfeeding is one of the most important practices for improving maternal and infant health. However, many mothers experience difficulties maintaining exclusive breastfeeding during the postpartum period. Psychological stress, anxiety, low breastfeeding confidence, and difficulties adapting to motherhood may negatively affect breastfeeding behaviors and contribute to early supplementation with formula or other foods.

Mindfulness-based approaches have been increasingly used to support maternal psychological well-being and health-related behaviors. These approaches aim to increase awareness of present-moment experiences in a non-judgmental manner and may help mothers engage more consciously in the breastfeeding process. Previous studies suggest that mindfulness-based interventions may improve maternal coping, emotional regulation, and breastfeeding experiences. However, evidence regarding their effectiveness among mothers who are not exclusively breastfeeding remains limited.

This randomized controlled trial aims to evaluate the effect of a mindfulness-based breastfeeding education program on breastfeeding awareness, breastfeeding self-efficacy, and exclusive breastfeeding rates among postpartum mothers who are not exclusively breastfeeding. Participants are randomly assigned to either a mindfulness-based breastfeeding education group or a control group receiving routine postpartum care. The intervention includes structured breastfeeding education combined with mindfulness-based practices conducted over four weeks. Outcomes are assessed at baseline, immediately after the intervention, and during follow-up assessments postpartum.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

Mindfulness-Based Breastfeeding Education Group

Behavioral

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.

Other names: mindful breastfeeding group

Primary outcomes

  1. Mindful Breastfeeding Scale

    Time frame: Baseline, 4th week postpartum, 4th month postpartum

    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.

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Official study title

EFFECT OF MINDFULNESS-BASED BREASTFEEDING EDUCATION PROGRAM ON BREASTFEEDING OUTCOMES IN MOTHERS NOT EXCLUSIVELY BREASTFEEDING: A RANDOMIZED CONTROLLED TRIAL

Acronym: MIND-BF

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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