- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06252311
The Effect of Mindfulness-Based Breastfeeding Programme in Mothers After Cesarean Delivery
The Effect of Mindfulness-Based Breastfeeding Programme on Breastfeeding Awareness and Breastfeeding Attitude in Mothers After Cesarean Delivery: A Randomised Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Oznur KORUKCU
- Phone Number: +90 505 385 67 76
- Email: oznurkorukcu@akdeniz.edu.tr
Study Contact Backup
- Name: Serife BUYUKOKUDAN
- Phone Number: +90 5546917092
- Email: serifebasir@hotmail.com
Study Locations
-
-
Dörtyol
-
Afyonkarahisar, Dörtyol, Turkey, 03030
- Not yet recruiting
- Afyonkarahisar Health Sciences University Health Application and Research Center
-
Contact:
- Serife BUYUKOKUDAN
-
Contact:
- Email: serifebasir@hotmail.com
-
Sub-Investigator:
- Serife BUYUKOKUDAN
-
-
Merkez
-
Afyonkarahisar, Merkez, Turkey
- Recruiting
- AFSU Health Research and Application Center
-
Contact:
- Buyukokudan, Serife
- Phone Number: +90 0 272 213 76 68
- Email: serifebasir@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mindful Breastfeeding Scale (MIND-BFS)
Time Frame: In the 2nd month after implementing the mindfulness-based breastfeeding program
|
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)
Time Frame: In the 2nd month after implementing the mindfulness-based breastfeeding program
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Infant Follow-up Form
Time Frame: 1st week, 2nd month, 4th month and 6th month after birth
|
Evaluation of the effect of mindfulness-based breastfeeding programme on the continuity of breastfeeding in women who underwent caesarean section.
This is a 7-question form designed by the researcher to assess the continuity of breastfeeding at specific time intervals, including questions such as adequate weight gain of the baby, breastfeeding status and feeding method
|
1st week, 2nd month, 4th month and 6th month after birth
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Oznur KORUKCU, Akdeniz University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AkdenizU-HF-SB-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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