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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07496307
Enrollment
82
Registered
2026-03-27
Start date
2025-11-01
Completion date
2026-09-06
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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 1-4 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.

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 1-4 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.

Interventions

BEHAVIORALStructured Breastfeeding Education

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.

Sponsors

Kahramanmaras Sutcu Imam University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Inclusion Criteria (Dahil Etme Kriterleri): Mothers with infants aged 1-4 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

Design outcomes

Primary

MeasureTime frameDescription
Breastfeeding Motivation Scale (for Primiparous Mothers)From the start of the intervention to 16 daysBreastfeeding 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.

Secondary

MeasureTime frameDescription
Maternal Attachment (Measured by Maternal Attachment Scale)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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATOREmel Güçlü Cihan, Assistant Professor

Kafkas University Training and Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026