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Recruiting NCT07409701

Gamification Intervertion in Children With Type 1 Diabetes

No phase Interventional Type 1 Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gamification.
Who it may be relevant to
Registry conditions: Type 1 Diabetes Mellitus. Basic parameters: 8 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Health Literacy Scale for Acute Complications of Diabetes in Children Aged 8-12 [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (1)
  • Quality of Life Scale for Children with Diabetes Mellitus [Time frame: Through study completion, an average of 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Etlik City Hospital — Ankara

Publications

  • Akın, B., & Koçoğlu, D. (2017). Randomize kontrollü deneyler. *Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi*, 4(1), 73-92. American Diabetes Association. (2023). Standards of medical care in diabetes-2023. *Diabetes Care*, 46(Supplement\_1), S1-S291. Altundağ, S. (2018). Tip 1 diyabetli çocukların hastalığa uyumunda eğitimin ve sosyal desteğin etkisi. *Pamukkale Tıp Dergisi*, 11(2):137-144.

Identifiers

NCT: NCT07409701 · 2025/061

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗