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临床试验/NCT07409701
NCT07409701招募中不适用

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

KTO Karatay University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2026年1月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
52
试验地点
1
主要终点
Health Literacy Scale for Acute Complications of Diabetes in Children Aged 8-12

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

education provided through gamification methods

Active Comparator

干预措施: Gamification (Other)

standard

No Intervention

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Quality of Life Scale for Children with Diabetes Mellitus(Through study completion, an average of 1 year)

研究者

发起方
KTO Karatay University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gülfidan Başer

Assistant Professor

KTO Karatay University

研究点 (1)

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