AzTrials
AzTrials

Self EfficacyNCT05435586

Digital Game Supported Breastfeeding Self-Efficacy, Breastfeeding Success

A study testing Web Based Breastfeeding Education and Counseling with Digital Game Support in people with Self Efficacy and Breast Feeding, Exclusive, run by Lokman Hekim University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 15 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Self Efficacy, Breast Feeding, Exclusive
What is being tested?
Web Based Breastfeeding Education and Counseling with Digital Game Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
13 Jan 2023to 30 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Primipara,
  • 32-36. 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Lokman Hekim University Etlik Hospital

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Digital Game Supported Web Based Breastfeeding Education and Counseling on Breastfeeding Self-Efficacy, Breastfeeding Success and Breast Problems: A Randomized Controlled Study

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.

Read more

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.

Read the detailed description

Breastfeeding has an important place in the healthy development of the baby, maternal benefits and mother-infant bonding. One of the most important factors affecting breastfeeding duration and success is the mother's perception of breastfeeding self-efficacy. In order to increase breastfeeding success and self-efficacy, it is very important for women to know about breastfeeding and the problems they may encounter. In the digital age, online training or access to online materials is easy and effortless. In the learning method with gamification, which has an important place in digital education, the behavior style that is intended to be taught to individuals can be taught more effectively and easily in accordance with the learning objectives. The inclusion and use of gamified features in web-based health interventions is known to increase user experience, increasing interest and fun.

In this study, it is thought that the Digital Game Supported Web-Based Breastfeeding Education and Counseling Program, which will be applied as individual sessions to women starting from the prenatal period until the postpartum 2nd month, will have positive effects on breastfeeding self-efficacy, breastfeeding success and breast problems. It is estimated that these results can guide professionals working with mothers and babies in the field and make a unique contribution to the field.

Being tested
Web Based Breastfeeding Education and Counseling with Digital Game Support
Keywords
gamification, breastfeeding self-efficacy, breastfeeding success, breast problems
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web Based Breastfeeding Education and Counseling with Digital Game SupportOther

    Also called Gamification

    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.

Study groups in NCT05435586
Study groupRoleWhat they receive
Web Based Breastfeeding Education and Counseling with Digital Game SupportExperimentalDuring 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.
Receives: Other: Web Based Breastfeeding Education and Counseling with Digital Game Support
Standardized breastfeeding educationNo interventionDuring 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: "pre-intervention"

  2. 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.

    Measured: "At the end of 37th gestational week."

  3. 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.

    Measured: "First day postpartum"

  4. 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.

    Measured: "First day postpartum"

  5. 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.

    Measured: "8 weeks postpartum"

Secondary outcomes (2)
  1. Breastfeeding Behavior and Breast Problems Evaluation Form

    The Breastfeeding Behavior and Breast Problems Evaluation Form, prepared by the researcher after a literature review, will be applied to the women in order to determine the breastfeeding behavior and breast problems of women in the postpartum period.

    Measured: "2 weeks postpartum"

  2. Breastfeeding Behavior and Breast Problems Evaluation Form

    The Breastfeeding Behavior and Breast Problems Evaluation Form, prepared by the researcher after a literature review, will be applied to the women in order to determine the breastfeeding behavior and breast problems of women in the postpartum period.

    Measured: "8 weeks postpartum"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2022
  2. Study start13 Jan 2023
  3. Primary completion30 Mar 2023
  4. Study completion30 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study is an experimental study with pretest-posttest parallel group randomized controlled.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05435586
Sponsor's protocol ID
Oyunlastirmailemzirme
Status last verified
Oct 2023
First submitted
1 Jun 2022
Last updated
5 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Web Based Breastfeeding Education and Counseling with Digital Game Support in people with Self Efficacy and Breast Feeding, Exclusive, run by Lokman Hekim University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breastfeeding Self-Efficacy Scale Short Form Antenatal score (time frame: "pre-intervention"). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in