search
Back to results

The Effect of Video Game on Children With Familial Mediterranean Fever

Primary Purpose

FMF

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
video game group
Education booklet group
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for FMF focused on measuring child, mobile game, disease management, quality of life, disease education

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University-CerrahpasaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

The control group

video game group

Education booklet group

Arm Description

no intervention

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 21, 2023
Last Updated
July 31, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
search

1. Study Identification

Unique Protocol Identification Number
NCT05980780
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
FMF
Keywords
child, mobile game, disease management, quality of life, disease education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Masking will be used when making the statistical evaluation of the results.
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The control group
Arm Type
No Intervention
Arm Description
no intervention
Arm Title
video game group
Arm Type
Experimental
Arm Description
Children in this group will play a video game for disease management
Arm Title
Education booklet group
Arm Type
Experimental
Arm Description
Children in this group will read an educational booklet for disease management.
Intervention Type
Behavioral
Intervention Name(s)
video game group
Intervention Description
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
Intervention Name(s)
Education booklet group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disease self-efficacy Self-Efficacy Scale for Pediatric Chronic Disease
Description
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.
Time Frame
before the intervention, immediately after the intervention, 2 months after the intervention
Title
Life quality
Description
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.
Time Frame
before the intervention, immediately after the intervention, 2 months after the intervention
Title
Disease information
Description
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.
Time Frame
before the intervention, immediately after the intervention, 2 months after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gamze KAŞ ALAY, MSc
Phone
+905452827600
Email
gamze_37_95@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birsen MUTLU, Phd
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gamze KAŞ ALAY, MSc

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34044626
Citation
Sparapani VC, Fels S, Kamal N, Ortiz La Banca R, Nascimento LC. A Video Game for Brazilian T1D Children about Knowledge of Disease and Self-care: A Methodological Study. J Diabetes Sci Technol. 2022 Nov;16(6):1444-1450. doi: 10.1177/19322968211017555. Epub 2021 May 28.
Results Reference
background
Citation
Rafeezadeh, E., Ghaemi, N., Miri, H.H., Rezaeian, A., (2019). Effect of an Educational Video Game for Diabetes Self-management on Adherence to a Self-care Regimen in Children with Type 1 Diabetes. Evidence Based Care Journal, 9 (1), 74-83.
Results Reference
background
PubMed Identifier
21500520
Citation
Nascimento Lda S, de Gutierrez MG, De Domenico EB. [Educative programs based on self-management: an integrative review]. Rev Gaucha Enferm. 2010 Jun;31(2):375-82. doi: 10.1590/s1983-14472010000200024. Portuguese.
Results Reference
background
PubMed Identifier
30938266
Citation
Migita K, Asano T, Sato S, Koga T, Fujita Y, Kawakami A. Familial Mediterranean fever: overview of pathogenesis, clinical features and management. Immunol Med. 2018 Jun;41(2):55-61. doi: 10.1080/13497413.2018.1481579. Epub 2018 Sep 7.
Results Reference
background
PubMed Identifier
23742958
Citation
Hentgen V, Grateau G, Kone-Paut I, Livneh A, Padeh S, Rozenbaum M, Amselem S, Gershoni-Baruch R, Touitou I, Ben-Chetrit E. Evidence-based recommendations for the practical management of Familial Mediterranean Fever. Semin Arthritis Rheum. 2013 Dec;43(3):387-91. doi: 10.1016/j.semarthrit.2013.04.011. Epub 2013 Jun 3.
Results Reference
background
PubMed Identifier
34222806
Citation
Yildirim DG, Bakkaloglu SA, Acar ASS, Celik B, Buyan N. Evaluation of quality of life and its associations with clinical parameters in pediatric patients with familial Mediterranean fever. North Clin Istanb. 2021 Apr 26;8(3):255-260. doi: 10.14744/nci.2020.90093. eCollection 2021.
Results Reference
background
PubMed Identifier
33252389
Citation
Gezgin Yildirim D, Gonen S, Fidan K, Soylemezoglu O. Does Age at Onset Affect the Clinical Presentation of Familial Mediterranean Fever in Children? J Clin Rheumatol. 2022 Jan 1;28(1):e125-e128. doi: 10.1097/RHU.0000000000001637.
Results Reference
background
PubMed Identifier
35023655
Citation
Yildirim DG, Bakkaloglu SA, Soysal-Acar AS, Buyan N. Parental knowledge about familial Mediterranean fever: a cross-sectional study. Turk J Pediatr. 2021;63(6):1048-1055. doi: 10.24953/turkjped.2021.06.013.
Results Reference
background
Citation
Durmuş, S.Y., Ozlu, S.G., Cop, E., Bulbul, M. (2022). Health Related Quality of Life of Children Aged 2-18 Years with Familial Mediterranean Fever. Turkish Journal of Pediatric Disease, Elektronik yayın tarihi 24.02.2022 DOI: 10.12956/tchd.1013742
Results Reference
background
PubMed Identifier
26186934
Citation
Charlier N, Zupancic N, Fieuws S, Denhaerynck K, Zaman B, Moons P. Serious games for improving knowledge and self-management in young people with chronic conditions: a systematic review and meta-analysis. J Am Med Inform Assoc. 2016 Jan;23(1):230-9. doi: 10.1093/jamia/ocv100. Epub 2015 Jul 17. Erratum In: J Am Med Inform Assoc. 2018 Sep 1;25(9):1270-1271.
Results Reference
background
PubMed Identifier
28957355
Citation
Calle-Bustos AM, Juan MC, Garcia-Garcia I, Abad F. An augmented reality game to support therapeutic education for children with diabetes. PLoS One. 2017 Sep 28;12(9):e0184645. doi: 10.1371/journal.pone.0184645. eCollection 2017.
Results Reference
background
PubMed Identifier
32107073
Citation
Bravo L, Killela MK, Reyes BL, Santos KMB, Torres V, Huang CC, Jacob E. Self-Management, Self-Efficacy, and Health-Related Quality of Life in Children With Chronic Illness and Medical Complexity. J Pediatr Health Care. 2020 Jul-Aug;34(4):304-314. doi: 10.1016/j.pedhc.2019.11.009. Epub 2020 Feb 25.
Results Reference
background
PubMed Identifier
18083454
Citation
Baranowski T, Buday R, Thompson DI, Baranowski J. Playing for real: video games and stories for health-related behavior change. Am J Prev Med. 2008 Jan;34(1):74-82. doi: 10.1016/j.amepre.2007.09.027.
Results Reference
background

Learn more about this trial

The Effect of Video Game on Children With Familial Mediterranean Fever

We'll reach out to this number within 24 hrs