The Effect of Mobile Application Game Training Designed for Children
NCT ID: NCT05633823
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
74 participants
INTERVENTIONAL
2023-04-10
2023-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In collecting research data; the Child and Parent Information Form, Inhaler Usage Skills Evaluation Form, Asthma Symptom and Treatment Need Scoring, DISABKIDS Asthma Scale will be used. A statistical package program (SPSS 20) will be used in the analysis of the research data. The statistical significance level was determined as 0.05. Kolmogorov-Smirnov will be used in the normality analysis of dependent variables. Chi-square and mean-to-means comparison tests will be used to determine the similarity of the groups. Appropriate parametric or non-parametric tests will be used according to the distribution's normality in comparing the means between groups and within groups.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Randomization will be provided by randomly and evenly dividing the patients who meet the sample selection criteria into 2 groups (1st experimental group, 2nd group control group) through a computer program (http://www1.assumption.edu/users/avadum/applets/). RandAssign/GroupGen.html).
* The data collection forms in the research will be applied to the children and parents in the sample group.
* Mobile application game training will be introduced to the children and parents in the experimental group and they will be provided to download the application to their mobile device or tablet.
* Data collection forms will be re-applied immediately after children complete one round of the game, 4 months and 6 months after the training.
* No application will be made to the children and parents in the control group, and the forms will be re-applied 4 months and 6 months after the first application of the data collection forms.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Game group
Children and parents will be introduced to mobile application game training and they will be provided to download the application to their mobile device or tablet. The data collection forms will be applied again immediately after the children complete each part of the game, 4 months and 6 months after the training.
Mobile Application Game Training
Mobile application game training can be used interactively with smartphones and tablets.
* A user account will be created after the application is downloaded to the mobile phone/tablet.
* After logging into the application, the map of the game will be displayed.
* The game will start with the first level of the game consisting of 5 levels.
* At each level, first of all, educational videos prepared in the form of short (1-2 minutes) animations will be watched. The number of videos varies between 1 and 3.
* After watching the videos, interactive games will be played.
* Children are required to complete each stage in the game, and each stage is planned to take approximately 7-10 minutes.
* After passing the first level, children will be able to move on to the next level of games and will not be able to move on to the next level until the previous level is finished.
Control group
No application will be made to children and parents, and the forms will be re-applied 4 months and 6 months after the first application of the data collection forms.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mobile Application Game Training
Mobile application game training can be used interactively with smartphones and tablets.
* A user account will be created after the application is downloaded to the mobile phone/tablet.
* After logging into the application, the map of the game will be displayed.
* The game will start with the first level of the game consisting of 5 levels.
* At each level, first of all, educational videos prepared in the form of short (1-2 minutes) animations will be watched. The number of videos varies between 1 and 3.
* After watching the videos, interactive games will be played.
* Children are required to complete each stage in the game, and each stage is planned to take approximately 7-10 minutes.
* After passing the first level, children will be able to move on to the next level of games and will not be able to move on to the next level until the previous level is finished.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Having been diagnosed with asthma according to ICD-10 in the last year
* Being on an inhaled corticosteroid or leukotriene antagonist (LTA)
* Not having any other chronic disease
* Having a phone/tablet with a parent or a mobile gameplay feature
* No communication, mental or neurological problems
* Volunteering to participate in the study
* Not being obese (3-90% percentile value)
* Moderate or severe asthma according to asthma severity classification
Exclusion Criteria
* Not having been diagnosed with asthma according to ICD-10 in the last year
* Having had a viral infection in the last two weeks
* Not using inhaled corticosteroids
* Having another chronic disease
* Not having a parent or a phone/tablet with mobile gameplay feature
* Having a communication, mental or neurological problem
* Not volunteering to participate in the study
* Being obese (more than 90% percentile)
* Mild asthma according to asthma severity classification
8 Years
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tarsus University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Atiye Karakul
Ass. Prof.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Duygu Sönmez Düzkaya
Role: PRINCIPAL_INVESTIGATOR
Tarsus University
Gamze Bozkul
Role: PRINCIPAL_INVESTIGATOR
Tarsus University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tarsus State Hospital
Mersin, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Al Aloola NA, Nissen L, Alewairdhi HA, Al Faryan N, Saini B. Parents' asthma information needs and preferences for school-based asthma support. J Asthma. 2017 Nov;54(9):946-956. doi: 10.1080/02770903.2017.1281296. Epub 2017 Jan 17.
Arikan-Ayyildiz Z, Isik S, Caglayan-Sozmen S, Anal O, Karaman O, Uzuner N. Efficacy of asthma education program on asthma control in children with uncontrolled asthma. Turk J Pediatr. 2016;58(4):383-388. doi: 10.24953/turkjped.2016.04.006.
Bruggers CS, Baranowski S, Beseris M, Leonard R, Long D, Schulte E, Shorter A, Stigner R, Mason CC, Bedrov A, Pascual I, Bulaj G. A Prototype Exercise-Empowerment Mobile Video Game for Children With Cancer, and Its Usability Assessment: Developing Digital Empowerment Interventions for Pediatric Diseases. Front Pediatr. 2018 Apr 9;6:69. doi: 10.3389/fped.2018.00069. eCollection 2018.
Castro-Rodriguez JA, Forno E, Rodriguez-Martinez CE, Celedon JC. Risk and Protective Factors for Childhood Asthma: What Is the Evidence? J Allergy Clin Immunol Pract. 2016 Nov-Dec;4(6):1111-1122. doi: 10.1016/j.jaip.2016.05.003. Epub 2016 Jun 8.
Cheng J, Wang H, Zhang X, Guo H, Duan H. The factors of family management affecting asthma control status in school-age children with asthma in China. J Asthma. 2022 May;59(5):1041-1050. doi: 10.1080/02770903.2021.1895209. Epub 2021 Mar 22.
Cook KA, Modena BD, Simon RA. Improvement in Asthma Control Using a Minimally Burdensome and Proactive Smartphone Application. J Allergy Clin Immunol Pract. 2016 Jul-Aug;4(4):730-737.e1. doi: 10.1016/j.jaip.2016.03.005. Epub 2016 Apr 20.
Davis SR, Peters D, Calvo RA, Sawyer SM, Foster JM, Smith LD. A consumer designed smartphone app for young people with asthma: pilot of engagement and acceptability. J Asthma. 2021 Feb;58(2):253-261. doi: 10.1080/02770903.2019.1680997. Epub 2019 Nov 6.
Deniz PÖ, Abacıgil F, Uysal P. Çocuk ve Ergenlerde Disabkids Astım Modülünün Geçerlilik ve Güvenilirliği. 4. Uluslararası 22. Ulusal Halk Sağlığı Kongresi, 2020.
Fedele DA, McConville A, Graham Thomas J, McQuaid EL, Janicke DM, Turner EM, Moon J, Abu-Hasan M. Applying Interactive Mobile health to Asthma Care in Teens (AIM2ACT): Development and design of a randomized controlled trial. Contemp Clin Trials. 2018 Jan;64:230-237. doi: 10.1016/j.cct.2017.09.007. Epub 2017 Oct 3.
Fedele DA, Thomas JG, McConville A, McQuaid EL, Voorhees S, Janicke DM, Abu-Hasan M, Chi X, Gurka MJ. Using Mobile Health to Improve Asthma Self-Management in Early Adolescence: A Pilot Randomized Controlled Trial. J Adolesc Health. 2021 Dec;69(6):1032-1040. doi: 10.1016/j.jadohealth.2021.06.011. Epub 2021 Jul 15.
Franzmair J, Diesner-Treiber SC, Voitl JJM, Voitl P. Effective German and English Language mHealth Apps for Self-management of Bronchial Asthma in Children and Adolescents: Comparison Study. JMIR Mhealth Uhealth. 2021 May 19;9(5):e24907. doi: 10.2196/24907.
Fuemmeler BF, Holzwarth E, Sheng Y, Do EK, Miller CA, Blatt J, Rosoff PM, Ostbye T. Mila Blooms: A Mobile Phone Application and Behavioral Intervention for Promoting Physical Activity and a Healthy Diet Among Adolescent Survivors of Childhood Cancer. Games Health J. 2020 Aug;9(4):279-289. doi: 10.1089/g4h.2019.0060. Epub 2020 May 8.
Gibson PG, Powell H, Coughlan J, Wilson AJ, Abramson M, Haywood P, Bauman A, Hensley MJ, Walters EH. Self-management education and regular practitioner review for adults with asthma. Cochrane Database Syst Rev. 2003;(1):CD001117. doi: 10.1002/14651858.CD001117.
Haktanir Abul M, Phipatanakul W. Severe asthma in children: Evaluation and management. Allergol Int. 2019 Apr;68(2):150-157. doi: 10.1016/j.alit.2018.11.007. Epub 2019 Jan 14.
Hsia B, Mowrey W, Keskin T, Wu S, Aita R, Kwak L, Ferastraoarou D, Rosenstreich D, Jariwala SP. Developing and pilot testing ASTHMAXcel, a mobile app for adults with asthma. J Asthma. 2021 Jun;58(6):834-847. doi: 10.1080/02770903.2020.1728770. Epub 2020 Feb 19.
Ivory, A.H., Ivory, J.D. (2017). On the Need for Developmental Perspectives in Research on the Potential Positive and Negative Health Effects of Digital Games. In: Marston, H., Freeman, S., Musselwhite, C. (eds) Mobile e-Health. Human-Computer Interaction Series. Springer
Kelada L, Molloy CJ, Hibbert P, Wiles LK, Gardner C, Klineberg E, Braithwaite J, Jaffe A. Child and caregiver experiences and perceptions of asthma self-management. NPJ Prim Care Respir Med. 2021 Sep 9;31(1):42. doi: 10.1038/s41533-021-00253-9.
Kindi ZA, McCabe C, McCann M. Impact of Nurse-Led Asthma Intervention on Child Health Outcomes: A Scoping Review. J Sch Nurs. 2022 Feb;38(1):84-97. doi: 10.1177/10598405211003303. Epub 2021 Mar 24.
Kulikova A, Lopez J, Antony A, Khan DA, Persaud D, Tiro J, Ivleva EI, Nakamura A, Patel Z, Tipton S, Lloyd T, Allen K, Kaur S, Owitz MS, Pak RJ, Adragna MS, Chankalal R, Humayun Q, Lehman HK, Miller BD, Wood BL, Brown ES. Multivariate Association of Child Depression and Anxiety with Asthma Outcomes. J Allergy Clin Immunol Pract. 2021 Jun;9(6):2399-2405. doi: 10.1016/j.jaip.2021.02.043. Epub 2021 Mar 4.
Lin J, Wang W, Tang H, Huo J, Gu Y, Liu R, Chen P, Yuan Y, Yang X, Xu J, Sun D, Li N, Jiang S, Chen Y, Wang C, Yang L, Liu X, Yang D, Zhang W, Chen Z, Lin Q, Liu C, Zhou J, Zhou X, Hu C, Jiang P, Zhou W, Zhang J, Cai S, Qiu C, Huang M, Huang Y, Liu H; China Asthma Research Collaboration Network. Asthma Management Using the Mobile Asthma Evaluation and Management System in China. Allergy Asthma Immunol Res. 2022 Jan;14(1):85-98. doi: 10.4168/aair.2022.14.1.85.
Liu AH, Zeiger R, Sorkness C, Mahr T, Ostrom N, Burgess S, Rosenzweig JC, Manjunath R. Development and cross-sectional validation of the Childhood Asthma Control Test. J Allergy Clin Immunol. 2007 Apr;119(4):817-25. doi: 10.1016/j.jaci.2006.12.662. Epub 2007 Mar 13.
Lv S, Ye X, Wang Z, Xia W, Qi Y, Wang W, Chen Y, Cai X, Qian X. A randomized controlled trial of a mobile application-assisted nurse-led model used to improve treatment outcomes in children with asthma. J Adv Nurs. 2019 Nov;75(11):3058-3067. doi: 10.1111/jan.14143. Epub 2019 Aug 12.
Lyons EJ, Baranowski T, Basen-Engquist KM, Lewis ZH, Swartz MC, Jennings K, Volpi E. Testing the effects of narrative and play on physical activity among breast cancer survivors using mobile apps: study protocol for a randomized controlled trial. BMC Cancer. 2016 Mar 9;16:202. doi: 10.1186/s12885-016-2244-y.
Masoli M, Fabian D, Holt S, Beasley R; Global Initiative for Asthma (GINA) Program. The global burden of asthma: executive summary of the GINA Dissemination Committee report. Allergy. 2004 May;59(5):469-78. doi: 10.1111/j.1398-9995.2004.00526.x. No abstract available.
Meyer R, Wang K, Yearley A, Grob S, Zeitlin J, Bloomfeld J, You M, Lee D, Bonner M, Shah N, Page K. Usability and Acceptability of the QuestLeukemia Mobile Application: A Pilot Study for An Educational and Psychological Intervention for Children with Chronic Illnesses. J Pediatr Hematol Oncol Nurs. 2022 May-Jun;39(3):137-142. doi: 10.1177/27527530221068422. Epub 2022 Jan 25.
Pearce N, Ait-Khaled N, Beasley R, Mallol J, Keil U, Mitchell E, Robertson C; ISAAC Phase Three Study Group. Worldwide trends in the prevalence of asthma symptoms: phase III of the International Study of Asthma and Allergies in Childhood (ISAAC). Thorax. 2007 Sep;62(9):758-66. doi: 10.1136/thx.2006.070169. Epub 2007 May 15.
Ramsey RR, Plevinsky JM, Kollin SR, Gibler RC, Guilbert TW, Hommel KA. Systematic Review of Digital Interventions for Pediatric Asthma Management. J Allergy Clin Immunol Pract. 2020 Apr;8(4):1284-1293. doi: 10.1016/j.jaip.2019.12.013. Epub 2019 Dec 21.
Real FJ, Beck AF, DeBlasio D, Zackoff M, Henize A, Xu Y, Davis D, Cruse B, Klein MD. Dose Matters: A Smartphone Application to Improve Asthma Control Among Patients at an Urban Pediatric Primary Care Clinic. Games Health J. 2019 Oct;8(5):357-365. doi: 10.1089/g4h.2019.0011. Epub 2019 Jun 3.
Sarasmita MA, Larasanty LPF, Kuo LN, Cheng KJ, Chen HY. A Computer-Based Interactive Narrative and a Serious Game for Children With Asthma: Development and Content Validity Analysis. J Med Internet Res. 2021 Sep 13;23(9):e28796. doi: 10.2196/28796.
Tark R, Metelitsa M, Akkermann K, Saks K, Mikkel S, Haljas K. Usability, Acceptability, Feasibility, and Effectiveness of a Gamified Mobile Health Intervention (Triumf) for Pediatric Patients: Qualitative Study. JMIR Serious Games. 2019 Sep 30;7(3):e13776. doi: 10.2196/13776.
GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.
Weinstein SM, Pugach O, Rosales G, Mosnaim GS, Orozco K, Pappalardo AA, Martin MA. Psychosocial Moderators and Outcomes of a Randomized Effectiveness Trial for Child Asthma. J Pediatr Psychol. 2021 Jul 20;46(6):673-687. doi: 10.1093/jpepsy/jsab011.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022/13
Identifier Type: -
Identifier Source: org_study_id