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临床试验/NCT05649553
NCT05649553已完成不适用

The Effect of Diabetes Education Given to Children With Type 1 Diabetes Mellitus With Digital Games and Video Animation on Quality of Life

Pamukkale University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Change in HbA1c

研究概览

简要总结

This research will be conducted to evaluate the effect of digital game and video animation-based diabetes education on the quality of life of children with Type 1 Diabetes. HbA1c, diabetes knowledge and Quality of Life Scale in Children with Diabetes (PedsQL 3.0) score will be taken into consideration when evaluating the quality of life of children with type 1 diabetes.

详细描述

This research was conducted to examine the effects of diabetes education given to children with Type 1 Diabetes Mellitus with digital game and video animation on quality of life and metabolic control. The study is a single-blind, randomized controlled trial. It was conducted with a total of 55 children with Type 1 Diabetes Mellitus, including the experimental (n=27) and control group (n=28). Diabetes education was given to the experimental group with digital games and video animations. Data were collected before the training, at the 3rd and 6th months after the training. Research data were collected with "Descriptive Information Form", "Quality of Life Scale in Children with Diabetes Mellitus" and "Metabolic Control Parameters Follow-up Form". Children in the control group received routine outpatient examination/check-up and diabetes education by a diabetes nurse. Children in the intervention group were given digital game and video animation-based training, as well as routine outpatient examination/check-up and training given by a diabetes nurse.

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 (Participant)

盲法说明

Single blinding was provided that included inclusion criteria and agreement to participate in the study.

入排标准

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

入选标准

  • Children's willingness to participate in the research (written consent of their parents, verbal consent was obtained from the children),
  • Being between the ages of 8-12,
  • Having been diagnosed with Type 1 Diabetes Mellitus at least 1 year ago
  • To have regular follow-ups,
  • No communication disability (speech, hearing, vision problems)
  • It means having a device (computer) with internet connection at home and being able to use it.

排除标准

  • Having any chronic disease together with diabetes,
  • Using an insulin pump

结局指标

主要结局

Change in HbA1c

时间窗: Baseline, 3. and 6. months

Measuring the changes in HbA1c levels of children with type 1 diabetes before training and at the 3rd and 6th months after training.

次要结局

  • Changes in quality of life(Baseline, 3. and 6. months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamze Tınmaz Pehlivan

PhD, Principal Investigator

Pamukkale University

研究点 (1)

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