Digital Respiratory Game in Asthma

NCT05930847 | Completed

• 1 other identifier: 2023/16
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma in Children

Keywords

Digital game; Pediatric asthma; Quality of life; Respiratory training; Psychological status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The Pediatric Asthma Quality of Life Questionnaire (PAQLQ)

  6 months

• Childhood Depression Inventory (CDI)

  4 months

Study Arms (2)

Digital game group

EXPERIMENTAL

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; Drug: Use of medication for asthma

Routine medical treatment group

ACTIVE COMPARATOR

The children continued their current asthma treatment in the same way. They did not receive any extra treatment.

Drug: Use of medication for asthma

Interventions

Digital Game Application DEVICE

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.

Digital game group

Use of medication for asthma DRUG

The children continued to take their current asthma medication on the same schedule. The drugs used by the children were zespira and ventolin.

Digital game group; Routine medical treatment group

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with asthma according to GINA criteria
• Cooperative

You may not qualify if:

• Presence of neurological problems
• Presence of systemic disorders

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege university faculty of health sciences

Izmir, Karsıyaka, 35575, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 5, 2023
• Study Start: February 20, 2022
• Primary Completion: April 20, 2022
• Study Completion: June 20, 2022
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TU (1)