The Effect of Video Game on Children With Familial Mediterranean Fever

NCT05980780 | Unknown DMC

• 1 other identifier: 2023-KAEK-7
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

FMF

Keywords

child; mobile game; disease management; quality of life; disease education

Outcome Measures

Primary Outcomes (3)

• 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.

  before the intervention, immediately after the intervention, 2 months after the intervention

• 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.

  before the intervention, immediately after the intervention, 2 months after the intervention

• 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.

  before the intervention, immediately after the intervention, 2 months after the intervention

Study Arms (3)

The control group

NO INTERVENTION

no intervention

video game group

EXPERIMENTAL

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

Behavioral: video game group

Education booklet group

EXPERIMENTAL

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

Behavioral: Education booklet group

Interventions

video game group 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.

video game group

Education booklet group 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.

Education booklet group

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Any identified mental disability
• Speech and communication difficulties

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (13)

• 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.

  PMID: 34044626 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 21500520 BACKGROUND

• 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.

  PMID: 30938266 BACKGROUND

• 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.

  PMID: 23742958 BACKGROUND

• 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.

  PMID: 34222806 BACKGROUND

• 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.

  PMID: 33252389 BACKGROUND

• 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.

  PMID: 35023655 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 26186934 BACKGROUND

• 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.

  PMID: 28957355 BACKGROUND

• 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.

  PMID: 32107073 BACKGROUND

• 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.

  PMID: 18083454 BACKGROUND

Study Officials

• Birsen MUTLU, Phd

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Central Study Contacts

Gamze KAŞ ALAY, MSc

CONTACT

+905452827600; gamze_37_95@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking will be used when making the statistical evaluation of the results.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 8, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 8, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)