NCT06344806

Brief Summary

This study aimed to evaluate the effect of a gamification-based breastfeeding education program on breastfeeding self-efficacy and infant feeding attitudes among pregnant women. The study was designed as a randomized controlled, pretest-posttest, parallel-group trial and was conducted in the antenatal outpatient clinics of Lokman Hekim Etlik Hospital. Eligible pregnant women were randomly assigned to either an intervention group or a control group. The intervention group received breastfeeding education delivered through a digital gamification-based program during the last trimester of pregnancy, while the control group received routine breastfeeding education as part of standard antenatal care. Data were collected before and after the educational intervention. The primary focus of the study was to compare changes in breastfeeding self-efficacy and infant feeding attitudes between the two groups following the intervention. The findings of this study are expected to contribute to the growing evidence on the use of innovative digital and gamification-based educational approaches in antenatal breastfeeding education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

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

February 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

March 22, 2024

Last Update Submit

January 26, 2026

Conditions

Keywords

breastfeedinggamificationeducation

Outcome Measures

Primary Outcomes (2)

  • breastfeeding self-efficacy

    Breastfeeding self-efficacy was measured using the Breastfeeding Self-Efficacy Scale-Short Form, Antenatal Version (BSES-SF). The scale consists of 14 items with total scores ranging from 14 to 70. Higher scores indicate greater breastfeeding self-efficacy.

    One week before the intervention and two weeks after completion of the intervention.

  • infant feeding attitudes

    Infant feeding attitudes were assessed using the Iowa Infant Feeding Attitude Scale (IIFAS). The scale includes 17 items with total scores ranging from 17 to 85. Higher scores reflect more positive attitudes toward breastfeeding.

    One week before the intervention and two weeks after completion of the intervention.

Study Arms (2)

Gamified Breastfeeding Education

EXPERIMENTAL

Participants in this arm receive a structured breastfeeding education program delivered through a digital platform incorporating gamification elements during the last trimester of pregnancy.

Behavioral: Gamified Breastfeeding Education

Standard Antenatal Breastfeeding Education

ACTIVE COMPARATOR

Participants in this arm receive routine breastfeeding education provided as part of standard antenatal care services at the hospital.

Behavioral: Gamified Breastfeeding Education

Interventions

Breastfeeding education content will be integrated into the game program designed with the gamification technique. A training program will be applied to the women in the experimental group in the last trimester. Women in the control group will receive the standard breastfeeding training in the hospital. Measurement tools will be applied to all participants before and after the training.

Gamified Breastfeeding EducationStandard Antenatal Breastfeeding Education

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primipara,
  • Between 27-40 weeks of gestation,
  • Those who have not received breastfeeding training before,
  • Able to speak and understand Turkish,
  • Women with a smart phone/tablet/computer with internet connection will be included in the study.

You may not qualify if:

  • Having a high risk pregnancy
  • with a condition that prevents breastfeeding
  • fetus with abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

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 GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer PhD

Study Record Dates

First Submitted

March 22, 2024

First Posted

April 3, 2024

Study Start

February 1, 2023

Primary Completion

March 30, 2023

Study Completion

May 30, 2023

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

This study will be conducted to determine the effect of breastfeeding education given through gamification on breastfeeding self-efficacy and infant feeding attitudes of pregnant women.

Locations