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Recruiting NCT07409701

Gamification Intervertion in Children With Type 1 Diabetes

◆ AI Clinical Summary

This study tests whether learning about type 1 diabetes through gamification (game-based learning) helps children better manage their condition and improves their quality of life. Children will be randomly assigned to receive either standard diabetes education or education delivered through interactive games and challenges.

Key Objective: The trial is testing whether game-based diabetes education improves health literacy and quality of life in children with type 1 diabetes.

Who to Consider: Children diagnosed with type 1 diabetes who are interested in trying a new, game-based approach to diabetes education may want to consider enrolling.

Trial Parameters

Condition Type 1 Diabetes Mellitus
Sponsor KTO Karatay University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 52
Sex ALL
Min Age 8 Years
Max Age 12 Years
Start Date 2026-01-25
Completion 2026-04-30
Interventions
Gamification

Brief 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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Presence of speech, hearing, or visual impairments * Presence of any other comorbid chronic disease * Presence of cognitive impairment

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