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临床试验/NCT05980780
NCT05980780招募中不适用

Video Developed for Children With Familial Mediterranean Fever The Effect of Game on Disease Management and Quality of Life

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
45
试验地点
1
主要终点
Life quality

研究概览

简要总结

This study was planned to be carried out as a pretest-posttest control group design in experimental type and randomized groups in order to determine the effect of educating children aged 8-14 with a diagnosis of Familial Mediterranean Fever through a mobile game application and training booklet on their disease knowledge, disease self-efficacy, symptom management and quality of life.

H0: Informing children with Familial Mediterranean Fever through mobile games and educational booklets has no effect on the child's knowledge of the disease, disease self-efficacy, symptom management and quality of life.

Compared to children with Familial Mediterranean Fever who were informed by mobile games, and children with Familial Mediterranean Fever who were informed through the education booklet and were not informed at all; H1: Disease knowledge increases. H2: Disease self-efficacy increases. H3: The number of attacks, activity intolerance, number of symptoms and severity of pain decrease.

H4: Quality of life increases.

详细描述

Today, with the ease of access to technological tools, the use of mobile technologies by children, adolescents and health professionals is becoming increasingly common. These technologies have begun to change the way healthcare professionals provide healthcare services, and support children's participation in their own care by providing easy-to-use digital services. It is emphasized that these technologies, which are accepted with interest by children and young people, are important new tools in providing health-related behavior change in children. One of these channels is video games developed for health. The use of video games in education as a method of children's choice is an important channel that will enable them to feel that they are in control of their own lives at an earlier age. Thus, these alternative education methods for children and adolescents can make a difference in patient education and management of chronic diseases. In the literature, it has been shown that video games are used and effective in psychotherapy practices and oral and dental health education, especially in the management of chronic diseases such as diabetes, cancer and asthma. However, no study has been found on disease self-management and education in children for Familial Mediterranean Fever, which is very common in our country and continues throughout life. We think that under the control of Familial Mediterranean Fever, which is a chronic disease, the child's self-management will manage the disease better, the frequency of attacks and hospital admissions will decrease, and future complications can be prevented.

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)

盲法说明

Masking will be used when making the statistical evaluation of the results.

入排标准

年龄范围
8 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Having been diagnosed with FMF (early 1 month)
  • Taking colchicine medication
  • Having an attack at least once a year
  • Willingness to participate in the research
  • His family's consent to participate in the research
  • Being literate

排除标准

  • Any identified mental disability
  • Speech and communication difficulties

结局指标

主要结局

Life quality

时间窗: before the intervention, immediately after the intervention, 2 months after the intervention

A Multi-Dimensional Assessment Scale for Children with Autoinflammatory Disease (JAIMAR) consists of 16 items in total, including assessment of functional skills, pain, compliance with drug use, and quality of life. The measure of quality of life; physical status, social status, school status and emotional status sub-dimensions are available. In addition, the form includes descriptive questions to be used in patient follow-up. In the scale scoring, 5-point Likert-type rating (Never=1, Rarely=2, Sometimes=3, Frequently=4, Always=5) is used in the sub-dimensions of quality of life (physical, social, school and emotional state), and the scoring is 1 It is done from th to 5th. After the average of the answers given to the questions in the criterion is taken, it is rescaled so that the highest score is 10. The quality of life criterion is calculated in the same way by using the average of the questions in all sub-criteria.

Disease self-efficacy Self-Efficacy Scale for Pediatric Chronic Disease

时间窗: before the intervention, immediately after the intervention, 2 months after the intervention

The Pediatric Self-Efficacy Scale for Chronic Disease (PRCISE) is an 11-point Likert-type scale consisting of 15 all positive items. The score of each item in the scale ranges from 0 to 10 and consists of statements such as "not sure at all" for 0 and "very sure" for 10. The scale, in which the level of self-efficacy increases as the score increases, is evaluated over 150 points.

Disease information

时间窗: before the intervention, immediately after the intervention, 2 months after the intervention

It is a short knowledge test of 11 questions, which was created by researchers and aims to measure disease knowledge. The questions in the test are closed-ended as yes/no, and the child who ticks yes is asked to write an explanation in the adjacent box.

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gamze Kas Alay

Research Assistant

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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