The Effect of Mindfulness-Based Breastfeeding Programme in Mothers After Cesarean Delivery

NCT06252311 | Recruiting

• 1 other identifier: AkdenizU-HF-SB-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

The study is a randomised controlled trial designed to determine the effect of the Mindfulness-Based Breastfeeding Programme on maternal breastfeeding awareness, breastfeeding attitudes and breastfeeding continuation among mothers who have given birth by caesarean section. The study will evaluate the effectiveness of the Mindfulness-Based Breastfeeding programme using the "Mindful Breastfeeding Scale" and "Iowa Infant Feeding Attitude Scale". The research will use stratified and simple randomisation methods. Research data will be collected from mothers who gave birth by caesarean section at the gynaecology clinic of the Afyonkarahisar Health Sciences University Health Application and Research Center of between April 2024 and December 2025.

Conditions

Breastfeeding

Keywords

Mindfulness; Breast Feeding; Attitude; Nursing

Outcome Measures

Primary Outcomes (2)

• Mindful Breastfeeding Scale (MIND-BFS)

  Evaluation of the effect of mindfulness-based breastfeeding programme on postpartum breastfeeding awareness in women who underwent cesarean section. The Mindful Breastfeeding Scale (MIND-BFS), is a 9-item instrument that assesses mindfulness-based breastfeeding practice in the postpartum period. The scale is unidimensional and developed in 5-point Likert format. The answers to the scale items vary from (1) always (5) never. The total score obtained from the scale ranges from 9 to 45, and as the total score obtained from the scale increases, the level of breastfeeding awareness increases. The Cronbach's alpha value of the scale was found to be 0.83.

  In the 2nd month after implementing the mindfulness-based breastfeeding program

• Iowa Infant Feeding Attitude Scale (IIFAS)

  Evaluation of the effect of mindfulness-based breastfeeding programme on postpartum breastfeeding attitude in women who underwent caesarean section. The Iowa Infant Feeding Attitude Scale (IIFAS) was to assess women's attitudes towards breastfeeding and predict the duration of breastfeeding and choice of infant feeding method. The scale comprises 17 items, each rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The scale includes 9 positive items about breastfeeding and 8 positive items about formula feeding, with the latter being reverse scored (1=5, 2=4, 4=2 and 5=1). The total attitude score ranges from 17 points (indicating a positive attitude towards bottle feeding) to 85 points (indicating a positive attitude towards breastfeeding).

  In the 2nd month after implementing the mindfulness-based breastfeeding program

Secondary Outcomes (1)

• Infant Follow-up Form

  1st week, 2nd month, 4th month and 6th month after birth

Study Arms (2)

Mindfulness-Based Breastfeeding Programme group

EXPERIMENTAL

Participants in the experimental group will receive the Mindfulness-Based Breastfeeding Programme, which consists of six 30-minute sessions within 0-72 hours. They will also be asked to complete a personal information form. In addition to the hospital sessions, educational materials, including home applications and audio recordings, will be sent via WhatsApp after discharge. During the first week after discharge, counselling will be provided by phone on the continuation of mindfulness-based practices, continuation of breastfeeding and problems related to breastfeeding, and referral to the health facility in case of problems, "Iowa Infant Feeding Attitude Scale" and "Mindful Breastfeeding Scale" will be administered by phone call in the 2nd month and finally the "Infant Feeding Follow-up Form" prepared by the researcher based on the literature will be used to assess the continuity of breastfeeding in the 1st week, 2nd month, 4th month and 6th month.

Behavioral: Mindfulness-Based Breastfeeding Programme

Control group

NO INTERVENTION

After the women in the control group have been informed about the study and have given their consent, they will complete a personal information form and then they will receive routine breastfeeding support and standard hospital care. The control group will be administered the Iowa Infant Feeding Attitude Scale and the Mindful Breastfeeding Scale by telephone interview at month 2 and the Infant Feeding Follow-up Form at week 1, month 2, month 4 and month 6.

Interventions

Mindfulness-Based Breastfeeding Programme BEHAVIORAL

Mindfulness-Based Breastfeeding Programme will consist of structure and anatomy of the breast and milk production, breast milk content, benefits of breast milk, breast care, frequency and duration of breastfeeding, correct and comfortable position for breastfeeding, effects of stress on lactation hormones and milk production, World Health Organization guidelines on duration and continuity of breastfeeding, time to start complementary feeding general information on recommendations, General information about breastfeeding with awareness, mentioning its purpose and programme flow, and it includes formal and informal practices such as breathing awareness exercises, noticing the autopilot, lying/sitting meditation, body scanning exercises and mindful breastfeeding practice.

Mindfulness-Based Breastfeeding Programme group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being between the ages of 18-40
• Having had a caesarean section at 37 weeks or more of gestation
• Having been hospitalised at Afyonkarahisar Health Sciences 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
• Hysterectomy after caesarean section
• 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

• Akdeniz University: lead

Study Sites (2)

Afyonkarahisar Health Sciences University Health Application and Research Center

Afyonkarahisar, Dörtyol, 03030, Turkey (Türkiye)

NOT YET RECRUITING

AFSU Health Research and Application Center

Afyonkarahisar, Merkez, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding; Behavior

Condition Hierarchy (Ancestors)

Feeding Behavior

Study Officials

• Oznur KORUKCU

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serife BUYUKOKUDAN

CONTACT

+90 5546917092; serifebasir@hotmail.com

Oznur KORUKCU

CONTACT

+90 505 385 67 76; oznurkorukcu@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the study, the researcher will not be blinded during the intervention implementation and data collection via telephone interviews. However, the control group will receive general breastfeeding education, allowing for participant blinding. Randomisation will be performed by an independent statistician using randomly generated numbers. Additionally, blinding of statisticians will be implemented during data entry and analysis by labelling primiparas in the experimental group as Xa and multiparas as Xb, and primiparas in the control group as Ya and multiparas as Yb
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sub-Investigator

Model Details: Participants are assigned to one of two groups with a Mindfulness-Based Breastfeeding Programme and control group

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 9, 2024
• Study Start: June 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)