Gamification Intervertion in Children With Type 1 Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorKTO Karatay University

About this trial

Objective: This study aims to examine the effect of education provided through gamification methods on health literacy and quality of life in children diagnosed with type 1 diabetes (T1DM).

Materials and Methods: The study is planned as a randomized controlled trial with a pre-test-post-test, parallel design (1:1). The data for the study will be collected between January and April 2026 from patients diagnosed with type 1 diabetes mellitus at the Ankara Etlik City Hospital Pediatric-2 Endocrinology Service. The sample size has been determined to be 52 patients, with 26 in each of the experimental and control groups, based on data from similar studies in the literature. Data will be collected through individual interviews using a Personal Information Form, the Health Literacy Scale for Acute Complications of Diabetes in Children Aged 8-12 with type 1 diabetes mellitus, and the Quality of Life Scale for Children with Diabetes Mellitus. The gamified education will be provided by a researcher who has completed a 2.5-hour training program from BTK Academy. Informed Consent Forms and other forms will be completed by patients who meet the inclusion criteria and volunteer to participate. Randomization will be performed by someone other than the researcher. The experimental group will receive gamified education in addition to standard education, while the control group will receive only standard education. Data will be analyzed using the SPSS program. The research will be conducted in accordance with the principles of the Helsinki Declaration.

Findings: The findings of the study will be analyzed using SPSS after the application and data collection are completed.

Conclusion: The results of the study will be written after the application of the study and the collection of data, followed by the analysis of the data using SPSS and the determination of the findings.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with type 1 diabetes

Aged between 8 and 12 years

Diagnosed with type 1 diabetes for at least 1 year and having received standard diabetes education

Able to read and write

Disqualifiers

Presence of speech, hearing, or visual impairments

Presence of any other comorbid chronic disease

Presence of cognitive impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gamification

    Other intervention

    This intervention will provide randomized controlled evidence on a gamified diabetes education program for children, an approach that is currently limited in Türkiye, thereby contributing to evidence-based practice. In addition, by adopting a holistic approach that jointly evaluates health literacy and psychological symptoms, the program aims not only to improve knowledge but also to enhance quality of life through an innovative and effective educational model.

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: education provided through gamification methodsActive comparator 1 intervention
Group B: standardNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Health Literacy Scale for Acute Complications of Diabetes in Children Aged 8-12

The scale developed by Çövener and Yeşil (2024) consists of 18 items and three subscales. A highly significant positive correlation was found between the total scale score and the subfactors of knowledge about acute complications of diabetes, interpretation of encountered problems, and healthy lifestyle behaviors (p=0.000). In other words, as the total scale score increases, the subfactor scores also increase.

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Quality of Life Scale for Children with Diabetes Mellitus

A linear conversion is applied in the calculation of the total score on the scale, converting it to a score between 0 and 100. If the answer to the question is marked as never, it receives 100 points; if marked as rarely, it receives 75 points; if marked as sometimes, it receives 50 points; if marked as often, it receives 25 points; and if marked as almost always, it receives 0 points. The higher the total score, the better the perceived health-related quality of life.

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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KTO Karatay University

Lead sponsor

Ankara Etlik City Hospital

Collaborator