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

NCT ID: NCT06252311

Last Updated: 2025-07-29

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

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Breastfeeding is an ideal form of nutrition that has important implications for the health of mothers, infants and society. In addition to its beneficial effects on biopsychosocial health, it also contributes to social development in economic terms. Because of the powerful effects of breastfeeding, various studies, practices and guidelines have been organised for the initiation and maintenance of breastfeeding. World Health Organization recommends initiation of breastfeeding within the first hour after birth, exclusive breastfeeding for the first 6 months and continued breastfeeding with complementary foods until the age of 2 years. However, in Turkey, exclusive breastfeeding for the first 6 months is 41% and the median duration of breastfeeding is 16.7 months. Although most women are willing and able to breastfeed, there are several factors that affect the initiation and continuation of breastfeeding. Studies of the difficulties in initiating and maintaining breastfeeding may portray breastfeeding as primarily a challenging and demanding behaviour, rather than a reciprocal act that provides a positive emotional exchange for both infant and mother. Mindfulness-based breastfeeding involves focusing on the present moment and experiencing breastfeeding moment by moment. This approach is based on the idea that breastfeeding is a time for the mother and baby to relax and is a natural process. It is believed that mindfulness-based breastfeeding can have positive effects. While there are studies in the international literature on the effects of mindfulness practices during pregnancy on breastfeeding, mindfulness-based childbirth education interventions, transition to mindfulness-based motherhood, and the effects of mindfulness-based practices on maternal self-efficacy, no study has evaluated the effect of a mindfulness-based breastfeeding programme on breastfeeding attitude and awareness after a cesarean section. This randomised controlled study was planned to investigate the effect of a mindfulness-based structured breastfeeding programme on breastfeeding awareness and breastfeeding attitude after caesarean section. In order to determine the sample size, 70 experimental and 70 control groups were determined to be sufficient according to the power analysis performed by using the G\*Power programme version 3.1 when the type-I error level (α)=0.05 and the power of the study was accepted as 0.90. Considering that women could not be provided with appropriate training due to pain and anaesthesia effect after caesarean section, sessions lasting 30 minutes were planned at hours when they felt comfortable and ready within 0-72 hours. The women in the experimental group will be trained a total of 6 sessions of mindfulness-based breastfeeding programme will be implemented, while the control group will be given rutin care. The research data will be collected by using Personal Information Form including sociodemographic characteristics, Iowa Infant Feeding Attitude Scale, Mindful Breastfeeding Scale and Infant Feeding Follow-up Form. As a result of the study, it is expected that breastfeeding awareness, breastfeeding attitude scores and breastfeeding continuity of the experimental group will be higher than the control group.

Conditions

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Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to one of two groups with a Mindfulness-Based Breastfeeding Programme and control group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
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

Study Groups

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Mindfulness-Based Breastfeeding Programme group

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.

Group Type EXPERIMENTAL

Mindfulness-Based Breastfeeding Programme

Intervention Type 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.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-Based Breastfeeding Programme

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

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
* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Serife BUYUKOKUDAN

Sub-Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oznur KORUKCU

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University

Locations

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Afyonkarahisar Health Sciences University Health Application and Research Center

Afyonkarahisar, Dörtyol, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

AFSU Health Research and Application Center

Afyonkarahisar, Merkez, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Serife BUYUKOKUDAN

Role: CONTACT

+90 5546917092

Oznur KORUKCU

Role: CONTACT

+90 505 385 67 76

Facility Contacts

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Serife BUYUKOKUDAN

Role: primary

Role: backup

Buyukokudan, Serife

Role: primary

+90 0 272 213 76 68

Other Identifiers

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AkdenizU-HF-SB-01

Identifier Type: -

Identifier Source: org_study_id

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