- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06742320
The Effect of Education Given to Children With Asthma (RCT)
April 8, 2026 updated by: Atiye Yıldırım, Dokuz Eylul University
Effect of Education on Asthma Knowledge, Control and Quality of Life in School-Age Children Diagnosed With Asthma
The aim of this study is to examine the effects of asthma education on asthma knowledge, control and quality of life of school-aged children (7-11 years old) diagnosed with asthma and followed up in the outpatient clinic.
Study Overview
Detailed Description
Asthma is among the most common chronic diseases in childhood.
Besides being one of the most common diseases, it is a preventable and controllable disease.In a study analyzing asthma data of children aged 0-17 by the Centers for Disease Control and Prevention (CDC), the prevalence of asthma was 8.7% in 2001, this rate increased to 9.4% in 2010, and decreased to 8.3% in 2016.
In the same study, the prevalence of asthma was found to be 9.2% in boys and 7.4% in girls.Asthma is also the leading cause of school absences in children ages 5 to 17, accounting for more than 14 million days of absence from school in 2013.These adverse effects of asthma can be minimized with appropriate education.Studies have found an increase in the quality of life of asthmatic students after asthma education, a decrease in asthma exacerbations, school absences, parental workday loss and medical expenses, and an increase in adherence to treatment, asthma knowledge and correct inhaler use.These findings suggest that asthma management interventions increase children's knowledge about their disease and their self-management skills.Based on this need, the aim of this study is to examine the effects of asthma education given to school-aged children (7-11 years old) diagnosed with asthma and followed up in the outpatient clinic on their asthma knowledge, control and quality of life.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Balcova
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Izmir, Balcova, Turkey (Türkiye), 35330
- Dokuz Eylul University Nevvar & Salih İşgören Children's Hospital Pediatric Allergy and Immunology Polyclinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being between the ages of 7-11,
- Medically diagnosed with asthma and being followed up in the outpatient clinic
- Family and child agreeing to participate in the study
- Ability to use a smartphone, computer or tablet
- Having internet access
- Children who can read and understand Turkish
Exclusion Criteria:
- Children who do not have a medical diagnosis of asthma
- Children who do not agree to participate in the study and their parents
- Children who do not complete the training and tests
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Education Group
Pre-test forms were applied to the children in the training group face to face by the researchers in the outpatient clinic.
Children assigned to the training group received asthma education in a single session, 3 modules/each module lasting at least 15 minutes.
Post-test forms were administered immediately after the training.The 2nd and 3rd follow-up tests will be administered online via Google Form in the 1st and 3rd months after the training is completed.
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There are very few studies examining the asthma knowledge level, quality of life and asthma control of children in Turkey.
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No Intervention: Control group
Pre-test forms will be applied to the control group face-to-face by researchers in the outpatient clinic.In the control group, follow-up tests (three weeks, 1 month and 3 months after the pre-tests) will be administered online via Google Form.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma Quality of Life Scale for Children
Time Frame: About 3 months
|
The scale was developed for children aged 7-11 and adapted to Turkish by Yüksel et al. (2009) and consists of 3 sub-dimensions, namely 'asthma symptoms', 'activity limitation' and 'emotional function', and 23 questions.
Scoring varies between 1-7 for each item.The total score to be obtained from the scale is between 23 and 161.
A high score indicates a good quality of life.
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About 3 months
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Childhood Asthma Control Test
Time Frame: About 3 months
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The scale evaluates asthma symptoms in the last 4 weeks for children aged 4-11.
Children answer the first 4 questions themselves, while the person responsible for the child's care answers the last 3 questions.
The total score to be obtained from the scale is between 0-27.
Patients with a total score of 19 points and below are considered to have uncontrolled asthma, and patients with a score of 20 points and above are considered to have controlled asthma.
|
About 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma Knowledge Survey
Time Frame: About 3 months
|
The asthma knowledge survey, which was created by the researchers by reviewing the relevant literature, consists of 13 questions.
The first 8 questions in the survey are about asthma definition, symptoms, triggers and physical activity status, and the last 5 questions are about asthma treatment.
The questions have a 3-point answer option of yes, no/I don't know. 1 point is received for correct answers and 0 points are received for wrong/I don't know.
There is a total distribution between 0-13 points.
The survey items were rearranged in line with the opinions received from 9 experts.
The content validity rates of the scores given by the experts to the items vary between 0.85-1.0.
The content validity index was calculated as 0.98 in the study.
It was determined that there was a high level and statistically significant consensus among the experts.
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About 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 25, 2024
Primary Completion (Actual)
April 15, 2025
Study Completion (Actual)
April 15, 2025
Study Registration Dates
First Submitted
December 16, 2024
First Submitted That Met QC Criteria
December 16, 2024
First Posted (Actual)
December 19, 2024
Study Record Updates
Last Update Posted (Actual)
April 9, 2026
Last Update Submitted That Met QC Criteria
April 8, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/10-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
I haven't decided yet.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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