Digital Respiratory Game in Asthma

Asthma in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05930847
• Other study ID #: 2023/16
• Status: Completed
• Phase: N/A
• Start date: February 20, 2022
• Est. completion date: June 20, 2022

Study information

• Verified date: April 2024
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 20, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

Inclusion Criteria:

• Diagnosed with asthma according to GINA criteria
• Cooperative

Exclusion Criteria:

• Presence of neurological problems
• Presence of systemic disorders

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ege university faculty of health sciences	Izmir	Karsiyaka

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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