Digital Respiratory Game in Asthma

• Sponsor: Ege University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05930847
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.9
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma in Children	Device: Digital Game Application; Drug: Use of medication for asthma	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Respiratory Training Digital Game on Respiratory Functions, and Psychological Status in Childhood Asthma
• Actual Study Start Date: Feb 20, 2022
• Actual Primary Completion Date: Apr 20, 2022
• Actual Study Completion Date: Jun 20, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Pulmonary Function Test [6 months]

   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.

Secondary Outcome Measures

1. Asthmatic Child Quality of Life Questionnaire [6 months]

   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.

2. Depression Scale for Children [4 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 7-17 age range

• Diagnosed with asthma according to GINA criteria

• Cooperative

Exclusion Criteria:

• Presence of neurological problems

• Presence of systemic disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ege university faculty of health sciences	İzmir	Karsıyaka	Turkey	35575

Sponsors and Collaborators

• Ege University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ozden Gokcek, Principal Investigator, Ege University
• ClinicalTrials.gov Identifier: NCT05930847
• Other Study ID Numbers: 2023/16
• First Posted: Jul 5, 2023
• Last Update Posted: Jul 5, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ozden Gokcek, Principal Investigator, Ege University: Digital game; Pediatric asthma; Quality of life; Respiratory training; Psychological status
• Additional relevant MeSH terms: Asthma

Study Results

No Results Posted as of Jul 5, 2023