The Effect of Video Game on Children With Familial Mediterranean Fever

NCT ID: NCT05980780

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-07-01

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.

Conditions

FMF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

The control group

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

video game group

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

Group Type: EXPERIMENTAL

video game group

Intervention Type: BEHAVIORAL

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.

Education booklet group

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

Group Type: EXPERIMENTAL

Education booklet group

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Gamze Kas Alay

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Birsen MUTLU, Phd

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Gamze KAŞ ALAY, MSc

Role: CONTACT

gamze_37_95@hotmail.com

+905452827600

Facility Contacts

Gamze KAŞ ALAY, MSc

Role: primary

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Other Identifiers

2023-KAEK-7

Identifier Type: -

Identifier Source: org_study_id