NCT06543238

Brief Summary

This study aims to determine the effects of breastfeeding education using the card game method on breastfeeding success and breastfeeding self-efficacy in primiparous breastfeeding mothers.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

August 4, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 9, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 4, 2025

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

August 4, 2024

Last Update Submit

February 28, 2025

Conditions

Keywords

PrimiparityMothersBreast FeedingSelf EfficacyEducationGame

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Self-Efficacy Scale

    The scale consists of a total of 14 items that evaluate breastfeeding self-efficacy. The scale is a 5-point Likert-type scale, and the items are evaluated by rating from 1 = "not sure at all" to 5 = "always sure". The lowest score that can be obtained from the scale is 14, the highest score is 70; higher scores indicate higher breastfeeding self-efficacy.

    36th week of pregnancy and postpartum

Secondary Outcomes (2)

  • LATCH Breastfeeding Diagnostic and Assessment Scale

    It will be applied to women in the control and experimental groups after birth.

  • Visual analog satisfaction scale

    It will be applied to women in experimental groups after birth.

Study Arms (2)

Breastfeeding card game

EXPERIMENTAL

Breastfeeding card game group: Breastfeeding education will be given to 30 primiparous pregnant women in the intervention group using the card game method twice, two weeks apart.

Other: Breastfeeding card game group

Control Group

NO INTERVENTION

No application will be made to this group by the researcher.

Interventions

Breastfeeding card game group: Breastfeeding education will be given to 30 primiparous pregnant women in the intervention group using the card game method twice, two weeks apart.

Breastfeeding card game

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince it is a study conducted on pregnant women, it concerns the female gender.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The conditions for volunteering to participate in the study are being over the age of 18, being able to read and write, being able to read and understand Turkish, not having hearing, speaking or visual impairments, having received breastfeeding training at a pregnancy school, being healthy in the 34th to 38th week of primiparous pregnancy, having a planned cesarean section, having a live birth and having a healthy baby.

You may not qualify if:

  • Obstacles to communication include having a visual, hearing or perception disorder, not being able to read or write, having a psychiatric illness, being multiparous and having a vaginal birth, having a risky pregnancy, not having a live birth and not having a live baby after birth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakine Yılmaz

Çankırı, None Selected, 18100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Sakine Yılmaz

    Çankırı Karatekin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Since the application will be performed by the researcher, patients will be blinded in this study. The statistician will be blinded in the evaluation of the data.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study consists of two groups: control and experimental group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Doctor

Study Record Dates

First Submitted

August 4, 2024

First Posted

August 7, 2024

Study Start

September 9, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

March 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations