Asthma in ChildrenNCT05930847
Digital Respiratory Game in Asthma
A study testing Digital Game Application and Use of medication for asthma in people with Asthma in Children, run by Ege University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Digital Game Application and Use of medication for asthma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2022to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with asthma according to GINA criteria
- Cooperative
Who cannot join
- Presence of neurological problems
- Presence of systemic disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege university faculty of health sciences
Izmir, Karsıyaka, 35575
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- Digital Game Application, Use of medication for asthma
- Keywords
- Digital game, Pediatric asthma, Quality of life, Respiratory training, Psychological status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Game ApplicationDevice
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.
Use of medication for asthmaDrug
The children continued to take their current asthma medication on the same schedule. The drugs used by the children were zespira and ventolin.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Use of medication for asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start20 Feb 2022
- Primary completion20 Apr 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozden Gokcek, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930847
- Sponsor's protocol ID
- 2023/16
- Status last verified
- Apr 2024
- First submitted
- 15 Jun 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sets generated and/or analyzed during the current study are available from the principal investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Respiratory Training Digital Game on Respiratory Functions, and Psychological Status in Childhood Asthma
- ClinicalTrials.gov ID
- NCT05930847
- Acronym / sponsor ID
- 2023/16
- Conditions
- Asthma in Children
- Keywords
- Digital game, Pediatric asthma, Quality of life, Respiratory training, Psychological status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital game group | Experimental | Device: Digital Game Application, Drug: Use of medication for asthmaIn 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. |
| Routine medical treatment group | Active comparator | Drug: Use of medication for asthmaThe children continued their current asthma treatment in the same way. They did not receive any extra treatment. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosed with asthma according to GINA criteria
- Cooperative
Key exclusion criteria (2 listed)
- Presence of neurological problems
- Presence of systemic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Game ApplicationThe 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. | Device | Digital game group |
| Use of medication for asthmaThe children continued to take their current asthma medication on the same schedule. The drugs used by the children were zespira and ventolin. | Drug | Digital game group, Routine medical treatment group |
Primary outcome
Pulmonary Function Test (PFT)
Time frame: 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.
2 secondary outcomes
The Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
Time frame: 6 months
Childhood Depression Inventory (CDI)
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: Yes. Data sets generated and/or analyzed during the current study are available from the principal investigator upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Game Application and Use of medication for asthma in people with Asthma in Children, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function Test (PFT) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.