The Effect of Video Game on Children With Familial Mediterranean Fever

Sponsor

Istanbul University - Cerrahpasa (IUC) (Other)

Overall Status

Recruiting

CT.gov ID

NCT05980780

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
FMF	Behavioral: video game group Behavioral: Education booklet group	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel AssignmentParallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: The control group no intervention
Experimental: video game group Children in this group will play a video game for disease management	Behavioral: video game group Pretest: Participants will be informed about FMF, treatment of FMF, side effects of treatment, factors that trigger attacks, symptoms that occur during the attack, symptom management/disease self-management, and coping with stress through a video game. At the beginning of the application, questions for the collection of demographic data and scales applied to the control group will be applied. The game will be played at home once a week for 1 month. For this, reminder messages will be sent once a week by obtaining the contact information of the mothers. Post-test 1: The scales will be re-administered 1 month after the pre-test. Post-test 2: The scales will be administered again 3 months after the pre-test.
Experimental: Education booklet group Children in this group will read an educational booklet for disease management.	Behavioral: Education booklet group Pretest: Participants will be informed about FMF, treatment of FMF, side effects of treatment, factors that trigger attacks, symptoms that occur during the attack, symptom management/disease self-management, and coping with stress through a training booklet. At the beginning of the application, questions for the collection of demographic data and scales applied to the control group will be applied. The booklet will be read at home once a week for 1 month. For this, reminder messages will be sent once a week by obtaining the contact information of the mothers. Post-test 1: The scales will be re-administered 1 month after the pre-test. Post-test 2: The scales will be administered again 3 months after the pre-test.

Arm

Intervention/Treatment

No Intervention: The control group

no intervention

Experimental: video game group

Children in this group will play a video game for disease management

Behavioral: video game group

Pretest: Participants will be informed about FMF, treatment of FMF, side effects of treatment, factors that trigger attacks, symptoms that occur during the attack, symptom management/disease self-management, and coping with stress through a video game. At the beginning of the application, questions for the collection of demographic data and scales applied to the control group will be applied. The game will be played at home once a week for 1 month. For this, reminder messages will be sent once a week by obtaining the contact information of the mothers. Post-test 1: The scales will be re-administered 1 month after the pre-test. Post-test 2: The scales will be administered again 3 months after the pre-test.

Experimental: Education booklet group

Children in this group will read an educational booklet for disease management.

Behavioral: Education booklet group

Pretest: Participants will be informed about FMF, treatment of FMF, side effects of treatment, factors that trigger attacks, symptoms that occur during the attack, symptom management/disease self-management, and coping with stress through a training booklet. At the beginning of the application, questions for the collection of demographic data and scales applied to the control group will be applied. The booklet will be read at home once a week for 1 month. For this, reminder messages will be sent once a week by obtaining the contact information of the mothers. Post-test 1: The scales will be re-administered 1 month after the pre-test. Post-test 2: The scales will be administered again 3 months after the pre-test.

Outcome Measures

Primary Outcome Measures

Disease self-efficacy Self-Efficacy Scale for Pediatric Chronic Disease [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.
Life quality [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 information [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.