Clinical trial NCT05980780: The Effect of Video Game on Children With Familial Mediterranean Fever
Official title: Video Developed for Children With Familial Mediterranean Fever The Effect of Game on Disease Management and Quality of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: FMF
Keywords: child
mobile game
disease management
quality of life
disease education
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 45
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Any identified mental disability
* Speech and communication difficulties

Primary outcomes:
measure: Disease self-efficacy Self-Efficacy Scale for Pediatric Chronic Disease
timeFrame: before the intervention, immediately after the intervention, 2 months after the intervention
measure: Life quality
timeFrame: before the intervention, immediately after the intervention, 2 months after the intervention
measure: Disease information
timeFrame: before the intervention, immediately after the intervention, 2 months after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Birsen MUTLU, Phd
role: STUDY_DIRECTOR
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