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Идёт набор NCT07409701

Gamification Intervertion in Children With Type 1 Diabetes

Без фазы С лечением Type 1 Diabetes Mellitus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Gamification.
Кому может быть актуально
Состояния в реестре: Type 1 Diabetes Mellitus. Базовые параметры: 8 лет — 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Другое 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.

Первичные конечные точки

  • Health Literacy Scale for Acute Complications of Diabetes in Children Aged 8-12 [Срок оценки: Through study completion, an average of 1 year]
Вторичные конечные точки (1)
  • Quality of Life Scale for Children with Diabetes Mellitus [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • Presence of speech, hearing, or visual impairments
  • Presence of any other comorbid chronic disease
  • Presence of cognitive impairment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

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

Публикации

  • 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.

Идентификаторы

NCT: NCT07409701 · 2025/061

Первоисточники (государственные реестры)

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