Structured Breastfeeding Education In Infants With Breast Refusal

March 23, 2026 updated by: Emel GÜÇLÜ CİHAN, Kahramanmaras Sutcu Imam University

The Impact Of Structured Breastfeeding Education On Sucking Function, Breastfeeding Motivation, And Mother-Infant Attachment In Infants With Breast Refusal: A Randomized Controlled Trial

This randomized controlled trial aims to examine the effects of structured breastfeeding education supported by midwives on the sucking skills of infants experiencing nipple refusal, maternal breastfeeding motivation, and mother-infant bonding. The study will be conducted with mothers who have infants aged 1-6 months and have been experiencing nipple refusal for at least 3 days and up to 30 days. Participants will be randomly assigned to either the intervention or control group; the intervention group will receive a one-week structured breastfeeding education program, while the control group will receive standard care. Following the education, online support will be provided for 15 days, and breastfeeding observations will be monitored. Sucking skills of the infants, mother-infant bonding, and maternal breastfeeding motivation will be assessed at both baseline and post-intervention evaluations.

Study Overview

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

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Kars
      • Kars, Kars, Turkey (Türkiye), 36100
        • Recruiting
        • Kafkas University Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Emel Güçlü Cihan, Assistant Professor, Kafkas University Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Actual)

January 15, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data from this study will not be shared publicly due to privacy and confidentiality concerns. Data include sensitive information about mothers and their infants, and sharing identifiable data could compromise participant privacy. Aggregate study results will be shared in publications and reports.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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