BreastfeedinggamificationNCT06344806
The Effect of Gamification on Breastfeeding Self-Efficacy and Infant Nutrition Attitudes of Pregnant Women
A study testing Gamified Breastfeeding Education in people with Breastfeeding, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Gamified Breastfeeding Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 30 May 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Having a high risk pregnancy
- with a condition that prevents breastfeeding
- fetus with abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breastfeeding Education Through Gamification on Breastfeeding Self-Efficacy and Infant Nutrition Attitudes of Pregnant Women: A Randomized Controlled Study
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.
Read the detailed description
This randomized controlled study was designed to evaluate the effectiveness of a gamification-based digital breastfeeding education program on breastfeeding self-efficacy and infant feeding attitudes among pregnant women. The study was conducted at the Obstetrics and Gynecology outpatient clinics of Lokman Hekim Etlik Hospital, where pregnant women are routinely followed during the antenatal period.
After being informed about the purpose and procedures of the study, pregnant women who agreed to participate provided written and verbal informed consent. Participants were allocated to the intervention or control group using a block randomization method to ensure balanced group sizes. The randomization sequence was generated by an independent statistician, and group assignments were concealed using sequentially numbered, opaque sealed envelopes. This process was implemented to reduce selection bias and strengthen the internal validity of the study.
The intervention consisted of a structured breastfeeding education program delivered through a digital platform incorporating gamification elements. The educational content was designed to increase participant engagement and motivation by integrating interactive and game-based components into standard breastfeeding education. The program was administered during the last trimester of pregnancy and focused on enhancing confidence in breastfeeding and fostering positive infant feeding attitudes.
Participants in the control group received routine breastfeeding education provided as part of standard antenatal care services at the hospital. This education reflected usual clinical practice and did not include digital or gamification-based components.
Data collection was conducted at baseline and following completion of the educational intervention. The study evaluated changes in breastfeeding-related psychosocial outcomes by comparing pre- and post-intervention assessments between the intervention and control groups.
This study aims to contribute to the evidence base on innovative digital education strategies in maternal health by examining the potential benefits of gamification-enhanced breastfeeding education during pregnancy. The findings are expected to support the development of engaging, technology-supported antenatal education programs to improve breastfeeding preparedness.
- Conditions
- Breastfeeding
- Being tested
- Gamified Breastfeeding Education
- Keywords
- breastfeeding, gamification, education
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified Breastfeeding EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Gamified Breastfeeding Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One week before the intervention and two weeks after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Feb 2023
- Primary completion30 Mar 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Özlem Ülkü BULUT, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344806
- Sponsor's protocol ID
- oyunlastirmabeslenme
- Acronym
- gamification
- Status last verified
- Jan 2026
- First submitted
- 22 Mar 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Bulut OU, Golbasi Z. The effect of gamified breastfeeding education on breastfeeding self-efficacy and infant feeding attitudes of pregnant women: a randomized controlled study. Rev Assoc Med Bras (1992). 2026 May 8;72(1):e20251003. doi: 10.1590/1806-9282.20251003. eCollection 2026.
PubMed 42138880
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeeding Education Through Gamification on Breastfeeding Self-Efficacy and Infant Nutrition Attitudes of Pregnant Women: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06344806
- Acronym / sponsor ID
- gamification / oyunlastirmabeslenme
- Conditions
- Breastfeeding
- Keywords
- breastfeeding, gamification, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized controlled study was designed to evaluate the effectiveness of a gamification-based digital breastfeeding education program on breastfeeding self-efficacy and infant feeding attitudes among pregnant women. The study was conducted at the Obstetrics and Gynecology outpatient clinics of Lokman Hekim Etlik Hospital, where pregnant women are routinely followed during the antenatal period.
After being informed about the purpose and procedures of the study, pregnant women who agreed to participate provided written and verbal informed consent. Participants were allocated to the intervention or control group using a block randomization method to ensure balanced group sizes. The randomization sequence was generated by an independent statistician, and group assignments were concealed using sequentially numbered, opaque sealed envelopes. This process was implemented to reduce selection bias and strengthen the internal validity of the study.
The intervention consisted of a structured breastfeeding education program delivered through a digital platform incorporating gamification elements. The educational content was designed to increase participant engagement and motivation by integrating interactive and game-based components into standard breastfeeding education. The program was administered during the last trimester of pregnancy and focused on enhancing confidence in breastfeeding and fostering positive infant feeding attitudes.
Participants in the control group received routine breastfeeding education provided as part of standard antenatal care services at the hospital. This education reflected usual clinical practice and did not include digital or gamification-based components.
Data collection was conducted at baseline and following completion of the educational intervention. The study evaluated changes in breastfeeding-related psychosocial outcomes by comparing pre- and post-intervention assessments between the intervention and control groups.
This study aims to contribute to the evidence base on innovative digital education strategies in maternal health by examining the potential benefits of gamification-enhanced breastfeeding education during pregnancy. The findings are expected to support the development of engaging, technology-supported antenatal education programs to improve breastfeeding preparedness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamified Breastfeeding Education | Experimental | Behavioral: Gamified Breastfeeding EducationParticipants in this arm receive a structured breastfeeding education program delivered through a digital platform incorporating gamification elements during the last trimester of pregnancy. |
| Standard Antenatal Breastfeeding Education | Active comparator | Behavioral: Gamified Breastfeeding EducationParticipants in this arm receive routine breastfeeding education provided as part of standard antenatal care services at the hospital. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Having a high risk pregnancy
- with a condition that prevents breastfeeding
- fetus with abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamified Breastfeeding EducationBreastfeeding 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. | Behavioural | Gamified Breastfeeding Education, Standard Antenatal Breastfeeding Education |
Primary outcome
breastfeeding self-efficacy
Time frame: One week before the intervention and two weeks after completion of the intervention.
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.
infant feeding attitudes
Time frame: One week before the intervention and two weeks after completion of the intervention.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Derived from this study: PubMed 42138880Bulut OU, Golbasi Z. The effect of gamified breastfeeding education on breastfeeding self-efficacy and infant feeding attitudes of pregnant women: a randomized controlled study. Rev Assoc Med Bras (1992). 2026 May 8;72(1):e20251003. doi: 10.1590/1806-9282.20251003. eCollection 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified Breastfeeding Education in people with Breastfeeding, 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 3 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 28 Jan 2026. 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 (time frame: One week before the intervention and two weeks after completion of the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06344806, which also lists 1 linked publication.
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 28 Jan 2026.