Clinical trial NCT05633823: The Effect of Mobile Application Game Training Designed for Children
Official title: The Effect of Mobile Application Game Training Designed for Children With Asthma on Asthma Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Life Style
Quality of Life
Lead sponsor: Tarsus University
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 74
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this research is to examine the effect of mobile application game training designed for children aged 8-16 years on asthma management and quality of life. The population of the study will be children in the 8-12 age group who applied to the Mersin Pediatric Allergy, Asthma and Immunology Specialist's clinic, and the sample will consist of 78 children with asthma who meet the criteria for inclusion in the research. This age group has problems in solving abstract problems, it is necessary to embody it in order to facilitate the understanding of the disease process. Therefore, it is important to embody the training given in the increase of self-management related to the disease process of this age group. While determining the sample size of the study, Arıkan-Ayyıldız et al. (2016) based on the scientific study named "Efficacy of asthma education program on asthma control in children with uncontrolled asthma". In the Arıkan-Ayyıldız study, it was reported that the total mean score of "ACT" (Asthma Control Test-Asthma Control Test) was 13.8±3.4 in the experimental group and 15.6±3.2 in the control group. As a result of the Power analysis (G\*Power 3.1.9.2) made according to these data; effect size = 0.78, with 95% confidence interval, 95% power, it was calculated that a total of 72 children with asthma, at least 36 in each group, should be included. Considering that there may be dropout and confounders during the research process, the number of groups was increased by 10%. The sample of the research; was a total of 78 children, including 39 children in each intervention group.

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: * Data will be collected in the waiting room after the child is examined at the clinic. In data collection, the pediatric patients who applied to the clinic of the Pediatric Allergy, Asthma and Immunology Specialist who met the inclusion criteria of the study and agreed to participate in the study, and their parents, who were diagnosed with asthma at least one year ago, will be informed about the purpose of the study and their parents, and their verbal and written consent will be obtained.
* 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.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 8-12
* 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 to be between the ages of 8-12
* 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

Primary outcomes:
measure: Using Inhaler Skill Evaluation Form
timeFrame: 1 day
measure: Asthma Symptom and Need for Treatment Scoring
timeFrame: 1 day
measure: DISABKIDS Asthma Scale
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Tarsus State Hospital
Study officials:
affiliation: Tarsus University
name: Duygu Sönmez Düzkaya
role: PRINCIPAL_INVESTIGATOR
affiliation: Tarsus University
name: Gamze Bozkul
role: PRINCIPAL_INVESTIGATOR
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