NCT07371845

Brief Summary

The aim of this randomized controlled experimental study is to contribute to the standardization of nursing interventions for premature mothers and to establish a scientific basis for breastfeeding education models in our country. It also aims to evaluate the effects of the following: digital privacy literacy, children's autonomy, decision-making ability, and privacy awareness. The hypotheses of the study are as follows: H₁: Mothers who received Teach-Back training have a higher level of breastfeeding self-efficacy. H₂: Mothers who received Teach-Back training have a higher level of mother-infant bonding. H₀: There is no significant difference between the groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

January 12, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

teach-backpreterm infantbreastfeeding success

Outcome Measures

Primary Outcomes (3)

  • Participant Introduction Form

    The form was prepared by the researcher in accordance with the literature to determine the sociodemographic (age, education level, income level, marital status, place of residence) and obstetric characteristics (number of pregnancies, mode of delivery, gestational age, birth weight, neonatal hospital stay, previous breastfeeding experience, etc.) of the mothers participating in the study. The form was developed using research examining the relationships between breastfeeding self-efficacy, mother-infant bonding, and maternal characteristics.

    First week

  • The Breastfeeding Self-Efficacy Scale for Mothers of Ill and/or Preterm Infants

    This scale was developed by Wheeler and Dennis (2013) and adapted into Turkish by Aluş Tokat et al. (2020). It is an 18-item scale with a 5-point Likert scale (1=Not sure at all, 2=Not sure at all, 3=Sometimes sure, 4= Sure, 5=Very sure). The minimum score obtainable on the scale is 18, and the maximum is 90. A higher score indicates high breastfeeding self-efficacy.

    First Week

  • Mother-to-Infant Bonding Scale

    This scale was developed by Taylor et al. (2005), and its Turkish validity and reliability study was conducted by Aydemir-Karakulak (2009). The scale consists of 8 items. It uses a 4-point Likert scale (1 = none - 4 = very much). Scores on the scale range from 0 to 24. The Cronbach alpha coefficient was found to be 0.683.

    First Week

Secondary Outcomes (3)

  • The Breastfeeding Self-Efficacy Scale for Mothers of Ill and/or Preterm Infants

    within the fist week

  • Mother-to-Infant Bonding Scale

    within the first week

  • Teach-Back Training Evaluation Form

    within the first week

Study Arms (2)

Teach-back Education Group

EXPERIMENTAL

Mothers receive teach-back education on breastfeeding and infant care.

Behavioral: Teach-Back Education

Control Group

NO INTERVENTION

Mothers receive routine care without teach-back education.

Interventions

A structured teach-back education program is provided to mothers of preterm infants to improve breastfeeding practices and enhance mother-infant bonding. Mothers are asked to repeat and demonstrate the information to confirm understanding.

Teach-back Education Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsprematüre bebek anneleri
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years of age or older,
  • Having a baby born before the 37th week of gestation (being a mother of a premature baby),
  • Being able to read and understand Turkish,
  • Having actually started breastfeeding,
  • Having no hearing, visual, or cognitive communication impairment,
  • Not having a diagnosed serious psychiatric illness (major depression, anxiety disorder, etc.),
  • The baby not being in a serious clinical condition, not under palliative care or intensive life support,
  • Not participating in another breastfeeding education or counseling program at the same time,
  • Voluntarily agreeing to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk Üniversitesi

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature BirthBreast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehavior

Study Officials

  • fatma güdücü tüfekci

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Data collection tools will be collected by an interviewer independent of the research.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants will be divided into two groups: an experimental group and a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Researcher

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 28, 2026

Study Start

December 1, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations