Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07409701

Gamification Intervertion in Children With Type 1 Diabetes

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gamification

Other

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 outcomes

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

    Time frame: Through study completion, an average of 1 year

    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.

Secondary outcomes

  1. Quality of Life Scale for Children with Diabetes Mellitus

    Time frame: Through study completion, an average of 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gülfidan Başer

CONTACT

[email protected]

4441251-7550

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Collaborators

  • Ankara Etlik City Hospital

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.