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

NCT06668467 | Completed

• 1 other identifier: 19.04.2023/59
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breastfeeding

Keywords

Breastfeeding self-efficacy; Mindfulness; Insufficient milk; Social support; Stress

Outcome Measures

Primary Outcomes (5)

• Mindful Breastfeeding Scale (MIND-BFS)

  The Mindful Breastfeeding Scale (MIND-BFS) is a 9-item measurement tool that evaluates awareness-based breastfeeding practices in the postpartum period. The scale is one-dimensional and was developed as a 5-point Likert type. Responses to the scale items vary from (1) Always to (5) Never. The total score to be obtained from the scale is scored between 9-45, and as the total score obtained from the scale increases, the awareness rate of breastfeeding also increases.

  Day 1, Day 7, Day 30 after delivery

• Breastfeeding Self-Efficacy Scale

  Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, the scale was reduced to 14 items by Dennis in 2003 and the Breastfeeding Self-Efficacy Scale Short Form was developed. The Turkish validity and reliability of the Breastfeeding Self-Efficacy Scale Short form was performed by Aluş Tokat and Okumus in 2009. This scale assesses how competent mothers feel about breastfeeding. The scale consists of 14 items and includes a 5-point Likert-type evaluation consisting of Not sure at all: 1, Not very sure: 2, Sometimes I am sure: 3, I am sure: 4, Very sure: 5 options. The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy.

  Day 1, Day 7, Day 30 after delivery

• Depression, Anxiety and Stress Scale (DASS-21)

  The scale consists of 21 items and three sub-dimensions. Each of the seven items that make up each sub-dimension of the scale measures depression, anxiety and stress. The DASS-21 scale is a four-point Likert-type scale and the items are evaluated between 0 and 3 (0 = not at all suitable for me, 1 = somewhat appropriate for me, 2 = usually suitable for me, 3 = completely suitable for me). There is no reverse item in the scale. The total scores of the scale range from 0 to 21 for each sub-dimension. In the validity and reliability study, the Cronbach-alpha coefficient was determined as 0.87 for the depression sub-dimension, 0.85 for the anxiety sub-dimension, and 0.81 for the stress sub-dimension. The Cronbach-alpha coefficient for the Turkish version of the Depression, Anxiety and Stress scale was determined as 0.88 for the depression sub-dimension, 0.80 for the anxiety sub-dimension and 0.87 for the stress sub-dimension

  Day 1, Day 7, Day 30 after delivery

• Multidimensional Scale of Perceived Social Support (MSPSS)

  MSPSS is a 12-item scale that measures the adequacy of social support. It consists of 3 subgroups that include items about family, friends and social support from a special person. It consists of 4 items for each group and each item is graded on a 7-item likert scale. A high total score indicates a high level of perceived social support.

  Day 1, Day 7, Day 30 after delivery

• Insufficient Milk Perception Scale

  The Insufficient Milk Perception Scale is a scale developed by McCarterSpaulding (2001) to measure mothers' beliefs about whether they produce sufficient milk. It consists of 6 questions. A minimum score of 0 and a maximum score of 50 can be obtained from this scale. A high score indicates that the mother's perception of adequate milk is high

  Day 1, Day 7, Day 30 after delivery

Study Arms (2)

Experimental

EXPERIMENTAL

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

Behavioral: Mindfulness-based Stress Reduction

Control

NO INTERVENTION

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

Interventions

Mindfulness-based Stress Reduction BEHAVIORAL

An 4-week Mindfulness-based stress reduction training programme

Experimental

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Famale
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being between the ages of 18-35
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

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

Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Leyla Kaya, PhD

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: November 4, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

TU (1)