Digital Respiratory Game in Asthma
Primary Purpose
Asthma in Children
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Digital Game Application
Use of medication for asthma
Sponsored by
About this trial
This is an interventional treatment trial for Asthma in Children focused on measuring Digital game, Pediatric asthma, Quality of life, Respiratory training, Psychological status
Eligibility Criteria
Inclusion Criteria: 7-17 age range Diagnosed with asthma according to GINA criteria Cooperative Exclusion Criteria: Presence of neurological problems Presence of systemic disorders
Sites / Locations
- Ege university faculty of health sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Digital game group
Routine medical treatment group
Arm Description
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.
The children continued their current asthma treatment in the same way. They did not receive any extra treatment.
Outcomes
Primary Outcome Measures
Pulmonary Function Test
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
Asthmatic Child Quality of Life Questionnaire
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.
Depression Scale for Children
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05930847
Brief Title
Digital Respiratory Game in Asthma
Official Title
Effect of Respiratory Training Digital Game on Respiratory Functions, and Psychological Status in Childhood Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
June 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children
Keywords
Digital game, Pediatric asthma, Quality of life, Respiratory training, Psychological status
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Digital game group
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine medical treatment group
Arm Type
Active Comparator
Arm Description
The children continued their current asthma treatment in the same way. They did not receive any extra treatment.
Intervention Type
Device
Intervention Name(s)
Digital Game Application
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Use of medication for asthma
Intervention Description
The children continued to take their current asthma medication on the same schedule. The drugs used by the children were zespira and ventolin.
Primary Outcome Measure Information:
Title
Pulmonary Function Test
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Asthmatic Child Quality of Life Questionnaire
Description
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.
Time Frame
6 months
Title
Depression Scale for Children
Description
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.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
7-17 age range
Diagnosed with asthma according to GINA criteria
Cooperative
Exclusion Criteria:
Presence of neurological problems
Presence of systemic disorders
Facility Information:
Facility Name
Ege university faculty of health sciences
City
İzmir
State/Province
Karsıyaka
ZIP/Postal Code
35575
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data sets generated and/or analyzed during the current study are available from the principal investigator upon reasonable request.
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Digital Respiratory Game in Asthma
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