NCT06918574

Brief Summary

The effect of the breastfeeding roadmap used in primiparous mothers on breastfeeding self-efficacy perception and breastfeeding success will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 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

First Submitted

Initial submission to the registry

March 28, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 9, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

March 28, 2025

Last Update Submit

July 28, 2025

Conditions

Keywords

Breastfeeding Roadmap

Outcome Measures

Primary Outcomes (5)

  • Sociodemographic characteristics

    Comparison of sociodemographic characteristics of women before the intervention with the questionnaire

    Within the first hour after the mother's birth.

  • Breastfeeding Self-Efficacy Short Form Scale

    Mothers whose pre-test data are collected will be assigned to intervention and control groups (Pre-test). The scale consists of 14 items. It is scored between 1-5 and the lowest 14 and the highest 70 points can be obtained. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.

    Within the first hour after the mother's birth.

  • Breastfeeding Self-Efficacy Short Form Scale

    Post-test data will be collected before mothers are discharged from the hospital (Post-test). The scale consists of 14 items. It is scored between 1-5 and the lowest 14 and the highest 70 points can be obtained. The higher the score obtained from the scale, the higher the breastfeeding self-efficacy.

    At least two hours before mothers are discharged from the hospital (the discharge period usually varies between 24 and 48 hours)

  • LATCH Breastfeeding Assessment Tool

    Mothers whose pre-test data are collected will be assigned to intervention and control groups (pre-test). The scale consists of five evaluation criteria and each item is evaluated between 0-2 points. The score that can be obtained from the measurement tool can vary between 0-10. The higher the score obtained from the scale, the higher the breastfeeding success.

    Within the first hour after the mother's birth

  • LATCH Breastfeeding Assessment Tool

    Post-test data will be collected before mothers are discharged from the hospital (Post-test). The scale consists of five evaluation criteria and each item is evaluated between 0-2 points. The score that can be obtained from the measurement tool can vary between 0-10. The higher the score obtained from the scale, the higher the breastfeeding success.

    At least two hours before mothers are discharged from the hospital (the discharge period usually varies between 24 and 48 hours)

Study Arms (2)

Intervention group

EXPERIMENTAL

In addition to the routine breastfeeding education given by the clinic's education nurse, the mothers in the intervention group will also receive a "Breastfeeding Roadmap" education poster prepared by the researchers, which will be hung on the wall of their rooms. The researcher will introduce the Breastfeeding Roadmap to the mothers and provide information on breastfeeding.

Other: Breastfeeding Education with Breastfeeding Roadmap

Control group

NO INTERVENTION

The control group of the study will receive routine breastfeeding education provided by the clinic's education nurse.

Interventions

Information about the "Breastfeeding Roadmap" prepared by the researchers will be explained to the mothers in the intervention group and hung in poster rooms.

Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer to participate in the study,
  • Primiparous,
  • Giving birth at 37 weeks of gestation or later,
  • No condition preventing breastfeeding,
  • No condition preventing breastfeeding in the baby,
  • At least primary school graduate,
  • Mothers aged 18 and over

You may not qualify if:

  • Those who have given birth to multiple pregnancies,
  • Those who received general anesthesia for Caesarean section,
  • Those who have any chronic disease, diagnosed mental or psychiatric illness history,
  • Those who have a history of preeclampsia, eclampsia and gestational diabetes,
  • Those whose babies are in intensive care after birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University Faculty of Medicine Hospital

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Ebru Bekmezci PhD

    Selcuk University

    PRINCIPAL INVESTIGATOR
  • Hediye Karakoç PhD

    KTO Karatay University

    PRINCIPAL INVESTIGATOR
  • Halime Esra Meram PhD

    Selcuk University

    PRINCIPAL INVESTIGATOR
  • Jule Eriç Horasanlı Doctor, ASSOCIATE PROFESSOR

    Necmettin Erbakan University Medical Faculty Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 9, 2025

Study Start

April 15, 2025

Primary Completion

July 26, 2025

Study Completion

July 28, 2025

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations