NCT07409701

Gamification Intervertion in Children With Type 1 Diabetes

The Effect of Education Provided to Children With Type 1 Diabetes Using Gamification Methods on Health Literacy and Quality of Life: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: KTO Karatay University · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Gamification	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.

Timeline

• Start date: 2026-01-25
• Primary completion: 2026-04-30
• Completion: 2026-08-30
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: Turkey (Türkiye)