Structured Breastfeeding Education In Infants With Breast Refusal

NCT07496307 | Recruiting

• 1 other identifier: MR-EM-8182-74
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breastfeeding Difficulties; Maternal Breastfeeding Motivation; Nipple Refusal; Mother-infant Bonding

Keywords

Breastfeeding; Nipple refusal; breastfeeding motivation; Infant feeding skills; Mother-infant bonding

Outcome Measures

Primary Outcomes (1)

• Breastfeeding Motivation Scale (for Primiparous Mothers)

  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 Outcomes (1)

• Maternal Attachment (Measured by Maternal Attachment Scale)

  16 days after the start of the intervention.

Study Arms (2)

Structured Breastfeeding Education

EXPERIMENTAL

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.

Behavioral: Structured Breastfeeding Education

Routine Postpartum Care

NO INTERVENTION

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).

Interventions

Structured Breastfeeding Education BEHAVIORAL

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.

Structured Breastfeeding Education

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kafkas University Training and Research Hospital

Kars, Kars, 36100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Emel Güçlü Cihan, Assistant Professor

  Kafkas University Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emel güçlü Güçlü Cihan, Assistant Professor

CONTACT

03443004913; emel_guclu4606@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No additional parties are blinded in this study. The study is open-label; participants, care providers, and investigators are aware of group assignments. Outcome assessments will be performed by the researchers.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned to two parallel groups: an intervention group receiving one-week structured breastfeeding education supported by midwives, and a control group receiving standard care. Both groups will be followed concurrently, and outcomes including infant sucking skills, maternal breastfeeding motivation, and mother-infant bonding will be compared at baseline and post-intervention.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 27, 2026
• Study Start: November 1, 2025
• Primary Completion: January 15, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)