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Completed

NCT Number: NCT05633823

The Effect of Mobile Application Game Training Designed for Children

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.

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Key information

Conditions

Asthma in Children Life Style Quality of Life

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tarsus State Hospital

Mersin, Turkey (Türkiye)

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Application Game Training

Other

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.

Primary outcomes

  1. Using Inhaler Skill Evaluation Form

    Time frame: 1 day

    The Skills Evaluation Form was prepared by using the brochure and literature prepared by the Turkish Respiratory Research Association Inhalation Therapies Working Group, based on correct inhalation techniques. The form consists of 10 skill steps in which the skills of using inhalation devices used in the treatment of asthma are evaluated. There are 4 subgroups in the form, including metered dose inhaler (MDI), turbohaler, discus and aerolizer type instruments. According to the scoring system used in the researches, "0" points are given for "Wrong" or skipped steps, and "1" points are given for "Correct" steps. A score between 0 and 10 is obtained by summing the scores obtained from all the steps evaluated by the direct observation method. The form will be filled by the same researcher using the observation method. In cases where more than one inhaler device is used, the average score will be taken. In the evaluation of the form; A high score indicates a good level of inhaler use.

  2. Asthma Symptom and Need for Treatment Scoring

    Time frame: 1 day

    This form was created to monitor the changes in the clinical symptoms of children with asthma (Liu et al., 2007; Al Aloola et al., 2017). It will be given at the beginning of the study so that the child and their parents can record their asthma symptoms. in form; respiratory tract complaints and asthma symptoms (cough, wheezing, shortness of breath, frequent breathing, phlegm, night cough), nasal complaints/ rhinitis symptoms (runny nose, congestion, sneezing, itchy eyes, watery eyes and itchy nose) no symptoms according to the degree of complaint It is scored as 0 if it is light, 2 if it is moderate, and 3 if it is heavy. These symptom scores will be calculated as asthma symptom score (ASS) and rhinitis symptom score (RSS) by giving the mean value. Total symptom score (TSS) will be taken as the sum of ASS and RSS.

  3. DISABKIDS Asthma Scale

    Time frame: 1 day

    The questions in the scale are evaluated using 1-5 point Likert type questions. "1" represents the most negative rating and "5" represents the most positive rating. The score weights of the questions are equal. The total score for all items is between 11-55. The scale has two sub-dimensions as effect and anxiety. There are 6 questions in the effect dimension and 5 questions in the anxiety dimension. In addition, there is an additional symptom section consisting of three questions for symptom control. This section is not included in the scoring, it provides an idea about the patient's asthma status. It is thought that the higher the score the patient gets from the scale, the better the quality of life. The cronbach alpha value of the scale is 0.86

Sponsors and collaborators

Lead sponsor

Tarsus University

Other

Registry information

Official study title

The Effect of Mobile Application Game Training Designed for Children With Asthma on Asthma Management

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2022
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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