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Completed

NCT Number: NCT05930847

Digital Respiratory Game in 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.

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Key information

Conditions

Asthma in Children

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege university faculty of health sciences

Izmir, Karsıyaka, 35575, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with asthma according to GINA criteria
  • Cooperative

Exclusion criteria

  • Presence of neurological problems
  • Presence of systemic disorders

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. The Pediatric Asthma Quality of Life Questionnaire (PAQLQ)

    Time frame: 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. Childhood Depression Inventory (CDI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

Effect of Respiratory Training Digital Game on Respiratory Functions, and Psychological Status in Childhood Asthma

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 5, 2023
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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