The Effect of Mindfulness-Based Stress Reduction on Maternal Perceived Milk Supply

NCT ID: NCT06668467

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2025-05-30

Brief Summary

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The aim of this study was to evaluate the effects of a mindfulness-based stress reduction (MBSR) programme on breastfeeding self-efficacy, stress, depression, anxiety and breastfeeding awareness in women with perceived breast milk insufficiency.

Detailed Description

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The aim of this study was to evaluate the effects of a mindfulness-based stress reduction (MBSR) programme on breastfeeding self-efficacy, stress, depression, anxiety and breastfeeding awareness in women with perceived breast milk insufficiency.

The study is designed as a single-blind, randomised controlled trial. It will be conducted between November 2024 and January 2025 at the Zeynep Kamil Women and Children's Diseases Education and Research Hospital.

Power analysis using G\*Power showed that at least 35 samples would be sufficient for 2 groups with an effect size of 0.5, 95% power and 5% margin of error. Participants to be included in the groups were selected from the sample using a random sampling method with an equal distribution ratio (distribution ratio = 1:1).

Eligible women were randomised to the intervention group (n=35) and the control group (n=35). Women allocated to the intervention group received the MBSR programme. MBSR was scheduled for 4 weekly sessions of 30 minutes each. The control group received routine hospital care but no other intervention during this period.

The pre-test data for the study were collected by the researcher using face-to-face interviews, a personal information form with demographic questions and the measurement tools used in the study. After one week and at the end of 4 weeks, the same measurement tools were used to collect post-test data.

Participants were given information about the MBSR programme and told how, for how long, and where they would practise. The online MBSR programme was completed by the participants in a specific way for each session (with mind, body and breathing exercises). The MBSR programme was delivered in this way for 4 weeks (eight sessions in total, two sessions per week). In addition, participants were given homework (audio recordings) to repeat the mindfulness meditation practices throughout the week (until the next session). At the end of the fourth week, the measures were administered again to participants who had attended all eight sessions and completed their homework, and post-test data were collected.

Conditions

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Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental

Women assigned to the experimental group will receive mindfulness-based stress reduction training for 4 weeks.

Group Type EXPERIMENTAL

Mindfulness-based Stress Reduction

Intervention Type BEHAVIORAL

An 4-week Mindfulness-based stress reduction training programme

Control

Women assigned to the control group will receive routine postpartum care services provided in the same hospital's outpatient clinics.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-based Stress Reduction

An 4-week Mindfulness-based stress reduction training programme

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Being between the ages of 18-35
* 37 weeks or more of gestation
* Primipar
* Having given birth vaginally
* University Health Application and Research Center, Gynaecology and Obstetrics Clinic
* Having a single and healthy baby (no multiple pregnancy)
* Having completed at least primary school
* Being able to communicate in Turkish by phone using the WhatsApp application
* The baby is with the mother

Exclusion Criteria

* Having a high-risk pregnancy
* Having a medical condition or taking medication that prevents breastfeeding
* Having a communication problems (vision, hearing, speech, language problems)
* Having a psychiatric illness
* There is an obstacle that prevents the baby from being with the mother or being in the neonatal intensive care unit
* Having a condition/disease that prevents you from doing mindfulness practices (breathing exercises, body scanning)
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Leyla Kaya

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leyla Kaya, PhD

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

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Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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19.04.2023/59

Identifier Type: -

Identifier Source: org_study_id

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