ClinicalTrials.gg
CompletedNCT05930847Updated Apr 30, 2024

Digital Respiratory Game in Asthma

An interventional study of Digital Game Application and Use of medication for asthma in Asthma in Children, sponsored by Ege University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 14 Years. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by Ege University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Feb 2022, registered Jun 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
8 Years to 14 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Asthma in Children

Keywords

  • Digital game
  • Pediatric asthma
  • Quality of life
  • Respiratory training
  • Psychological status
03

In context

Lead sponsor

Ege University is the lead sponsor of 375 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with asthma according to GINA criteria
  • Cooperative

Exclusion criteria

Exclusion Criteria:

  • Presence of neurological problems
  • Presence of systemic disorders
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • 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 · Drug: Use of medication for asthma

  • 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

Interventions

  • DeviceDigital 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.

  • DrugUse 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.

06

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 4 months

07

Study locations

1 site
  • Ege university faculty of health sciences
    Izmir, Karsıyaka 35575, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes — Data sets generated and/or analyzed during the current study are available from the principal investigator upon reasonable request.

Supporting information: Study protocol, Statistical analysis plan

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2022 to primary completion in Apr 2022, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 15, 2023
First posted
Jul 5, 2023
StartActual
Feb 20, 2022
Primary completionActual
Apr 20, 2022
CompletionActual
Jun 20, 2022
Last update
Apr 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05930847
Lead sponsor
Ege University
Responsible party
Ozden Gokcek (Principal Investigator, Ege University) — Principal investigator
First posted
Jul 5, 2023
Start date
Feb 20, 2022
Primary completion
Apr 20, 2022
Completion
Jun 20, 2022
Last update
Apr 30, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion