NCT07567755

Brief Summary

This randomized controlled trial aims to evaluate the effects of compassion-based breastfeeding counseling on self-compassion, mindful breastfeeding, and breastfeeding self-efficacy during the perinatal period. Pregnant women between 24-28 weeks of gestation who meet the eligibility criteria are enrolled. After obtaining informed consent, participants are randomly assigned to either the intervention or control group using simple randomization. The intervention group receives a total of 6 face-to-face compassion-based breastfeeding counseling sessions between 30-37 weeks of gestation, with follow-up counseling continued until 6 weeks postpartum. The control group receives only routine antenatal care with no additional intervention. Outcome measures are assessed at three time points: pretest (24-28 weeks of gestation), posttest (36-38 weeks of gestation), and follow-up (6 weeks postpartum). Instruments used include the Self-Compassion Scale, the Breastfeeding Self-Efficacy Scale-Short Form, and the Mindful Breastfeeding Scale. The study is conducted at Iğdır Dr. Nevruz Erez State Hospital, Türkiye.

Trial Health

87
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
Completed

Started May 2025

Shorter than P25 for not_applicable

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

May 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Keywords

Compassion-based counselingBreastfeeding self-efficacyMindful breastfeedingSelf-compassionPerinatal periodRandomized controlled trialAntenatal education

Outcome Measures

Primary Outcomes (3)

  • Breastfeeding Self-Efficacy

    Measured by the Breastfeeding Self-Efficacy Scale-Short Form (Turkish adaptation, Tokat Aluş et al., 2010). 14-item, 5-point Likert scale; scores range 14-70. Higher scores indicate greater self-efficacy.

    Baseline (24-28 weeks gestation), post-intervention (36-38 weeks gestation), and follow-up (6 weeks postpartum)

  • Self-Compassion

    Measured by the Self-Compassion Scale (Turkish adaptation, Deniz et al., 2008). 24-item, 5-point Likert scale; scores range 24-120. Higher scores indicate greater self-compassion.

    Baseline (24-28 weeks gestation), post-intervention (36-38 weeks gestation), and follow-up (6 weeks postpartum)

  • Mindful Breastfeeding

    Measured by the Mindful Breastfeeding Scale (Körükcü et al., 2021). 9-item, 5-point Likert scale; scores range 9-45. Higher scores indicate greater mindfulness during breastfeeding.

    Baseline (24-28 weeks gestation), post-intervention (36-38 weeks gestation), and follow-up (6 weeks postpartum)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Receives 6 face-to-face compassion-based breastfeeding counseling sessions between 30-37 weeks of gestation, with follow-up counseling continued until 6 weeks postpartum.

Behavioral: Compassion-Based Breastfeeding Counseling

Control Group

NO INTERVENTION

Receives routine antenatal care only, with no additional intervention.

Interventions

A structured, compassion-based breastfeeding counseling program consisting of 6 face-to-face sessions delivered between 30-37 weeks of gestation. Each session integrates self-compassion practices (based on Neff's self-compassion model), mindfulness-based breastfeeding techniques, and evidence-based breastfeeding education. Sessions address emotional barriers to breastfeeding, strengthen breastfeeding self-efficacy, and promote mindful mother-infant interaction. Follow-up counseling is continued until 6 weeks postpartum.

Intervention Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Literate or above
  • Primigravida
  • Between 18-35 years of age
  • Between 24-28 weeks of gestation
  • Spontaneous conception
  • Owns a smartphone

You may not qualify if:

  • Diagnosed with any psychiatric disorder (self-reported)
  • High-risk pregnancy (preeclampsia, gestational diabetes mellitus, placenta previa, chronic disease, fetal anomaly, multiple pregnancy, Rh incompatibility, obesity)
  • Previously attended any compassion or mindfulness-based training
  • Communication barriers (inability to speak Turkish, hearing/speech impairment, or intellectual disability)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Institute of Health Sciences, Ankara, Ankara 06000

Ankara, Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • ŞENGÜL YAMAN SÖZBİR, PhD

    Gazi University, Faculty of Health Sciences, Department of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to either the intervention group (compassion-based breastfeeding counseling) or the control group (routine antenatal care) using simple randomization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 5, 2026

Study Start

May 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations