Clinical trial NCT06252311: The Effect of Mindfulness-Based Breastfeeding Programme in Mothers After Cesarean Delivery
Official title: The Effect of Mindfulness-Based Breastfeeding Programme on Breastfeeding Awareness and Breastfeeding Attitude in Mothers After Cesarean Delivery: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breastfeeding
Keywords: Mindfulness
Breast Feeding
Attitude
Nursing
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups with a Mindfulness-Based Breastfeeding Programme and control group
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Mindful Breastfeeding Scale (MIND-BFS)
timeFrame: In the 2nd month after implementing the mindfulness-based breastfeeding program
measure: Iowa Infant Feeding Attitude Scale (IIFAS)
timeFrame: In the 2nd month after implementing the mindfulness-based breastfeeding program
Secondary outcomes:
measure: Infant Follow-up Form
timeFrame: 1st week, 2nd month, 4th month and 6th month after birth
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Sciences University Health Application and Research Center
state: Dörtyol
Study officials:
affiliation: Akdeniz University
name: Oznur KORUKCU
role: PRINCIPAL_INVESTIGATOR
References: