Digital Respiratory Game in Asthma

Effect of Respiratory Training Digital Game on Respiratory Functions, and Psychological Status in Childhood Asthma

This study aims to examine the effects of a digital game designed for respiratory training in childhood asthma. Fifteen children aged 8-14 years with asthma were included in the study. There were two groups a digital game group (n=9) and a control group (n=6). Respiratory training was given to the digital game group with a digital game. The control group was followed with medication. Both groups were evaluated at baseline and after 3 weeks.

Study Overview

• Status: Completed
• Conditions: Asthma in Children
• Intervention / Treatment: Device: Digital Game Application; Drug: Use of medication for asthma

Detailed Description

Asthma is a chronic obstructive disease that is common in children worldwide. This study aims to examine the effects of a digital game designed for respiratory training in childhood asthma.

Fifteen children aged 8-14 years with asthma were included in the study. There were two groups a digital game group (n=9) and a control group (n=6). Demographic information of the children was recorded. Pulmonary function test (PFT) was evaluated with a portable spirometer (Spirobank MIR), the quality of life of the children was evaluated with the Paediatric Asthma Quality of Life Questionnaire and psychological status was evaluated with the child depression scale. Respiratory training was given to the digital game group with a digital game. The control group was followed with medication. Both groups were evaluated at baseline and after 3 weeks.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karsıyaka
    • İzmir, Karsıyaka, Turkey, 35575
      • Ege University Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with asthma according to GINA criteria
• Cooperative

Exclusion Criteria:

• Presence of neurological problems
• Presence of systemic disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital game group; In addition to routine drug use, children of the digital game group were followed up with 15 sessions of 15 minutes of digital games for respiratory training.	Device: Digital Game Application; The digital game contains brief information about the respiratory system adapted to children, and it is a game whose duration can be adjusted manually to follow the treatment process of the patient, taking into account the ½ ratio in the inhalation and exhalation process in the clinic.; Drug: Use of medication for asthma; The children continued to take their current asthma medication on the same schedule. The drugs used by the children were zespira and ventolin.
Active Comparator: Routine medical treatment group; The children continued their current asthma treatment in the same way. They did not receive any extra treatment.	Drug: Use of medication for asthma; The children continued to take their current asthma medication on the same schedule. The drugs used by the children were zespira and ventolin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Function Test (PFT)	The respiratory function of the children was evaluated with a portable spirometer (Spirobank MIR, Italy) according to the European Respiratory Society (ERS) and American Thoracic Society (ATS) criteria. The test will be performed in a sitting position, with the patient asked to inhale deeply and then exhale rapidly through the spirometer.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Pediatric Asthma Quality of Life Questionnaire (PAQLQ)	It is used to evaluate the quality of life of children aged 7-17 years by measuring the physical, mental, and social impairment specific to asthma. It is a 23-item quality-of-life scale developed to measure the physical, mental, and social disorders of children with asthma. The total score for all items is 23-161. Higher scores suggest a better quality of life.	6 months
Childhood Depression Inventory (CDI)	The depression status of the children was evaluated with the Child Depression Scale. In this 27-item scale, 1,2,3 items are specified for each question and the scoring is done on a maximum of 54 points, with 0 for 1, 1 for 2 and 2 for 3. The cut-off score is recommended as 19 and the severity of depression increases as the score increases.	4 months

Collaborators and Investigators

• Sponsor: Ege University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2022
• Primary Completion (Actual): April 20, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Pediatric asthma; Psychological status; Respiratory training; Digital game
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2023/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sets generated and/or analyzed during the current study are available from the principal investigator upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No