NCT05435586

Brief Summary

Purpose: This study will be conducted to determine the effect of digital game supported web-based breastfeeding education and counseling on breastfeeding self-efficacy, breastfeeding success and breast problems. Method: This is an experimental study with a randomized controlled pretest-posttest parallel group, and 30 women will be included in the experimental group and 30 women in the control group. In the study, Pregnant Women's Individual and Obstetric Characteristics Evaluation Form, Breastfeeding Self-Efficacy Scale Short Form (EÖYÖ), LATCH Breastfeeding Assessment Tool, Breastfeeding Evaluation Scale (IBFAT), Breastfeeding Behavior and Breast Problems Evaluation Form will be used. The data will be analyzed in SPSS program. In the Digital Game Supported Web-Based Breastfeeding Education and Counseling Program, the educational content prepared by the researcher will be integrated into the game program designed with the gamification technique. An education program will be applied to the women in the experimental group during pregnancy and postpartum period. Women in the control group will receive the standard breastfeeding training in the hospital. Measurement tools will be applied to all participants for a total of three times, once before birth and twice after birth. Conclusion and Suggestions: In this planned study, it was aimed to teach women about breastfeeding in a digital environment in a fun way. It is thought that web-based breastfeeding education and counseling supported by digital games will have a positive effect on breastfeeding self-efficacy, breastfeeding success and breast problems.

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 Jan 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

First Submitted

Initial submission to the registry

June 1, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

January 13, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

June 1, 2022

Last Update Submit

October 3, 2023

Conditions

Keywords

gamificationbreastfeeding self-efficacybreastfeeding successbreast problems

Outcome Measures

Primary Outcomes (5)

  • Breastfeeding Self-Efficacy Scale Short Form Antenatal score

    Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, the scale was reduced to 14 items by Dennis in 2003 and the Breastfeeding Self-Efficacy Scale Short Form was developed. The Turkish validity and reliability of the Breastfeeding Self-Efficacy Scale Short form was performed by Aluş Tokat and Okumus in 2009. This scale assesses how competent mothers feel about breastfeeding. The scale consists of 14 items and includes a 5-point Likert-type evaluation consisting of Not sure at all: 1, Not very sure: 2, Sometimes I am sure: 3, I am sure: 4, Very sure: 5 options. The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy.

    "pre-intervention"

  • Breastfeeding Self-Efficacy Scale Short Form Antenatal score

    Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, the scale was reduced to 14 items by Dennis in 2003 and the Breastfeeding Self-Efficacy Scale Short Form was developed. The Turkish validity and reliability of the Breastfeeding Self-Efficacy Scale Short form was performed by Aluş Tokat and Okumus in 2009. This scale assesses how competent mothers feel about breastfeeding. The scale consists of 14 items and includes a 5-point Likert-type evaluation consisting of Not sure at all: 1, Not very sure: 2, Sometimes I am sure: 3, I am sure: 4, Very sure: 5 options. The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy.

    "At the end of 37th gestational week."

  • The Infant Breastfeeding Assesment Tool score

    The Infant Breastfeeding Assesment Tool (IBFAT) It was developed by Mary Kay Matthews in 1988. The scale is a measurement tool developed to determine temporary feeding difficulties in the first 4 to 5 days in healthy and term babies. The Turkish validity and reliability study of the scale was carried out by Çelik and Demirci, and the Cronbach alpha coefficient was calculated as 0.92 in this study. The scale consists of six questions and the evaluation is made by the mothers. Scoring is done on the basis of the mothers' answers to the questions. The first question in the scale is about the baby's feeding status (deep sleep, sleepy, calm awake, crying). In the last question, mothers are asked to state their feelings during feeding (Very satisfied, satisfied, not very satisfied, not satisfied). These two questions are not included in the scoring and are evaluated separately.

    "First day postpartum"

  • The LATCH Breastfeeding Diagnostic Tool

    The LATCH Breastfeeding Diagnostic Tool It was developed by Mary Kay Matthews in 1988. The scale is a measurement tool developed to determine temporary feeding difficulties in the first 4 to 5 days in healthy and term babies. The Turkish validity and reliability study of the scale was carried out by Çelik and Demirci, and the Cronbach alpha coefficient was calculated as 0.92 in this study. The scale consists of six questions and the evaluation is made by the mothers. Scoring is done on the basis of the mothers' answers to the questions. The first question in the scale is about the baby's feeding status (deep sleep, sleepy, calm awake, crying). In the last question, mothers are asked to state their feelings during feeding (Very satisfied, satisfied, not very satisfied, not satisfied). These two questions are not included in the scoring and are evaluated separately.

    "First day postpartum"

  • Breastfeeding Self-Efficacy Scale Short Form Postnatal score

    Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, the scale was reduced to 14 items by Dennis in 2003 and the Breastfeeding Self-Efficacy Scale Short Form was developed. The Turkish validity and reliability of the Breastfeeding Self-Efficacy Scale Short form was performed by Aluş Tokat and Okumus in 2009. This scale assesses how competent mothers feel about breastfeeding. The scale consists of 14 items and includes a 5-point Likert-type evaluation consisting of Not sure at all: 1, Not very sure: 2, Sometimes I am sure: 3, I am sure: 4, Very sure: 5 options. The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy.

    "8 weeks postpartum"

Secondary Outcomes (2)

  • Breastfeeding Behavior and Breast Problems Evaluation Form

    "2 weeks postpartum"

  • Breastfeeding Behavior and Breast Problems Evaluation Form

    "8 weeks postpartum"

Study Arms (2)

Web Based Breastfeeding Education and Counseling with Digital Game Support

EXPERIMENTAL

During pregnancy; * Application of the "Individual and Obstetrical Characteristics Evaluation Form of Pregnant Women" and "Breastfeeding Self-Efficacy Scale Antenatal Form" (Pre-Test).(32-34 weeks of gestation) * Program will be applied to 30 women at 35-37 gestational weeks. * Breastfeeding Self-Efficacy Scale (Antenatal form) will be applied to at the end of 37th gestational week. In the postpartum period; * The LATCH Breastfeeding Diagnostic Tool and Breastfeeding Assessment Scale (IBFAT) will be administered on the first postpartum day. * Program will be applied to 30 women during the first 2 weeks postpartum. * At the end of the postpartum 2nd week, Breastfeeding Behavior and Breast Problems Evaluation Form will be administered. * Breastfeeding Self-Efficacy Scale (Postpartum form) and Breast Problems Evaluation form will be administered at postpartum 8th week.

Other: Web Based Breastfeeding Education and Counseling with Digital Game Support

Standardized breastfeeding education

NO INTERVENTION

During pregnancy; * Application of the "Individual and Obstetrical Characteristics Evaluation Form of Pregnant Women" and "Breastfeeding Self-Efficacy Scale Antenatal Form" (Pre-Test).(32-34 weeks of gestation) * 30 women will receive the routine care applied during pregnancy in the hospital. * At the end of the 37th week, the Breastfeeding Self-Efficacy Scale (Antenatal form) will be administered to the women in the control group. In the postpartum period; * 30 women will receive the standard breastfeeding training in the hospital. * The LATCH Breastfeeding Diagnostic Tool and Breastfeeding Assessment Scale (IBFAT) will be administered on the first postpartum day. * At the end of the postpartum 2nd week, the Breastfeeding Behavior and Breast Problems Evaluation Form will be applied. * Breastfeeding Self-Efficacy Scale (Postpartum form) and Breastfeeding Behavior and Breast Problems Evaluation Form will be administered at the postpartum 8th week.

Interventions

The educational content prepared by the researcher on the web page will be integrated into the game program designed with the gamification technique. In this designed program, users will be notified at appropriate times to enter the system and play games from the link sent via e-mail. After the users have finished the game, they will fill the scale in the relevant week and will only be able to exit the system in that way.

Also known as: Gamification
Web Based Breastfeeding Education and Counseling with Digital Game Support

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Primipara,
  • between gestational weeks,
  • Those who have not received a planned breastfeeding training before,
  • Speaking and understanding Turkish,
  • Women with a smart phone/tablet/computer with internet connection will be included in the study.

You may not qualify if:

  • Having a chronic disease,
  • Those who will give birth by planned cesarean section,
  • Breastfeeding contraindications
  • Women with risky pregnancies will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim University Etlik Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Counseling

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The research data were collected on a web-based platform by the researcher, who did not know who was in the experimental and control groups, and transferred to the computer by someone else. A statistician analyzed the coded data in groups. Statistical analyzes have been completed.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study is an experimental study with pretest-posttest parallel group randomized controlled.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 28, 2022

Study Start

January 13, 2023

Primary Completion

March 30, 2023

Study Completion

July 30, 2023

Last Updated

October 5, 2023

Record last verified: 2023-10

Locations