- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07496307
Structured Breastfeeding Education In Infants With Breast Refusal
The Impact Of Structured Breastfeeding Education On Sucking Function, Breastfeeding Motivation, And Mother-Infant Attachment In Infants With Breast Refusal: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be conducted as a randomized controlled trial to determine the effects of structured breastfeeding education on the sucking skills of infants experiencing nipple refusal, maternal breastfeeding motivation, and mother-infant bonding. Participants will include mothers with infants aged 1-6 months who have experienced nipple refusal for 3 to 30 days. Written informed consent will be obtained from all participating mothers, and they will be randomly assigned to either the intervention or control group.
Mothers in the intervention group will receive structured breastfeeding education through individual or group sessions lasting one hour per day for one week. The education will cover topics such as nipple refusal, benefits of breast milk, breastfeeding techniques, methods to increase milk production, skin-to-skin contact, the importance of mother-infant bonding, and motivation-enhancing strategies. Following the education, participants will receive online support for 15 days, and breastfeeding progress will be monitored through daily observation forms.
The control group will receive only standard medical care, and an educational brochure will be provided after the study is completed. At baseline, mothers' demographic and obstetric information, infants' sucking skills, mother-infant bonding, and maternal breastfeeding motivation will be assessed. At the end of the education and follow-up period, a post-intervention evaluation will be conducted on day 16 using the same measurements, and the results will be compared.
This study aims to determine whether structured breastfeeding education improves the sucking skills of infants experiencing nipple refusal, strengthens mother-infant bonding, and positively influences maternal breastfeeding motivation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emel güçlü Güçlü Cihan, Assistant Professor
- Phone Number: 03443004913
- Email: emel_guclu4606@hotmail.com
Study Locations
-
-
Kars
-
Kars, Kars, Turkey (Türkiye), 36100
- Recruiting
- Kafkas University Training and Research Hospital
-
Contact:
- Emel güçlü Güçlü Cihan, Assistant Professor
- Phone Number: 03443004913
- Email: emel_guclu4606@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Inclusion Criteria (Dahil Etme Kriterleri):
Mothers with infants aged 1-6 months
Mothers of infants who have experienced nipple refusal for 3-30 days
Mothers who provide written informed consent
Mothers without pregnancy or postpartum complications
Mothers who are literate and able to understand the study questionnaires
Exclusion Criteria:
- Infants with serious congenital anomalies or health problems
Mothers with severe psychiatric or chronic illnesses
Any medical condition in the mother or infant that prevents participation
Mothers who refuse to complete the study or cannot comply with the follow-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Structured Breastfeeding Education
Mothers in this group will receive a one-week structured breastfeeding education program with midwife support.
The education includes guidance on nipple refusal, breastfeeding techniques, methods to increase milk production, skin-to-skin contact, importance of mother-infant bonding, and strategies to enhance maternal breastfeeding motivation.
Following the program, participants will receive daily online support for 15 days, and breastfeeding progress will be monitored through daily observation forms.
|
One-week, midwife-supported structured breastfeeding education for mothers of infants experiencing nipple refusal.
Includes guidance on breastfeeding techniques, nipple refusal management, milk production enhancement, skin-to-skin contact, mother-infant bonding, and motivation strategies.
Followed by 15 days of online support and daily breastfeeding monitoring.
|
|
No Intervention: Routine Postpartum Care
Mothers in the control group will receive routine medical care and standard postnatal guidance provided by the hospital.
No structured breastfeeding education or additional intervention will be provided during the study period.
After completion of the study, participants will be given educational materials (brochure).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breastfeeding Motivation Scale (for Primiparous Mothers)
Time Frame: From the start of the intervention to 16 days
|
Breastfeeding motivation will be assessed using the Breastfeeding Motivation Scale (BMS), developed by Peleg et al. (2015) and adapted into Turkish by Mızrak (2017).
The scale consists of 23 items rated on a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree).
The scale does not yield a total score; instead, subscale scores are calculated as the mean of the items.
Higher scores indicate higher motivation in the respective subscale.
|
From the start of the intervention to 16 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Attachment (Measured by Maternal Attachment Scale)
Time Frame: 16 days after the start of the intervention.
|
Maternal attachment will be assessed using the Maternal Attachment Scale (Maternal Bağlanma Ölçeği, MBÖ) developed by Muller (1994) and adapted into Turkish by Kavlak and Şirin (2009). The scale consists of 26 items rated on a 4-point Likert scale (1 = never, 4 = always). Total scores range from 26 to 104. Higher scores indicate higher maternal attachment. |
16 days after the start of the intervention.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Emel Güçlü Cihan, Assistant Professor, Kafkas University Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- MR-EM-8182-74
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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