- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07654712
Effectiveness of Education on Preventive Measures Against Acute Respiratory Tract Infections in School-Age Children
June 12, 2026 updated by: Aynur Aytekin Ozdemir, Istanbul Medeniyet University
Investigation of the Effectiveness of Education on Preventive Measures Against Acute Respiratory Tract Infections in School-Age Children: A Cluster Randomized Controlled Trial
This study aimed to evaluate the effectiveness of an animation video-supported education program on preventive measures against acute respiratory tract infections among first-grade primary school children.
Study Overview
Status
Completed
Conditions
Detailed Description
This study aimed to evaluate the effectiveness of an animation video-supported education program on preventive measures against acute respiratory tract infections among first-grade primary school children.
The study was conducted as a cluster randomized controlled trial in a public primary school in Istanbul, Türkiye.
Two first-grade classrooms were selected and randomly assigned to the intervention and control groups.
The intervention group received an animation video-supported education program on preventive measures against acute respiratory tract infections, while the control group received no education during the data collection period.
Outcomes were assessed at baseline and two weeks after completion of the intervention.
The primary outcomes included children's knowledge scores regarding preventive measures against respiratory tract infections, coughing/sneezing hygiene skill scores, and hand hygiene skill scores.
Study Type
Interventional
Enrollment (Actual)
48
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
-
-
Istanbul
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Istanbul, Istanbul, Turkey (Türkiye)
- Istanbul Medeniyet University
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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
Yes
Description
Inclusion Criteria:
- Being enrolled in the first grade of the primary school where the study was conducted
- Being able to speak and understand Turkish
- Having written informed consent from a parent or legal guardian
- Being willing to participate in the study
Exclusion Criteria:
- Having an acute respiratory tract infection during data collection
- Having any chronic disease
- Having a physical or cognitive impairment that prevents communication, watching the educational materials, or completing the measurement tools
- Not having written informed consent from a parent or legal guardian
- Not being willing to participate in the study
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Animation Video-Supported Education Group
Participants in the intervention group received an animation video-supported education program on preventive measures against acute respiratory tract infections.
The program was delivered in a classroom setting over three weeks, in three sessions, with a total duration of 120 minutes.
The content included respiratory infection transmission, actions to be taken during illness, hand hygiene, coughing/sneezing etiquette, avoidance of touching the face, social distancing, and healthy lifestyle recommendations.
|
The intervention consisted of an animation video-supported education program developed for first-grade primary school children.
The program included a 15-minute animation video, question-and-answer activities, demonstration and practice of coughing/sneezing etiquette, and demonstration and practice of hand hygiene using a handwashing station.
The education was delivered in three sessions over three weeks, with a total duration of 120 minutes.
|
|
No Intervention: Control Group
Participants in the control group did not receive any education on preventive measures against acute respiratory tract infections during the data collection period.
After completion of the post-test measurements, the education program was also provided to the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Knowledge Score on Preventive Measures Against Respiratory Tract Infections
Time Frame: Baseline and two weeks after completion of the intervention
|
Children's knowledge regarding preventive measures against respiratory tract infections was assessed using the Knowledge Form on Preventive Measures Against Respiratory Tract Infections.
The form consists of 7 items.
Each correct answer is scored as 1 point and each incorrect answer is scored as 0 points.
Total scores range from 0 to 7, with higher scores indicating a higher level of knowledge.
|
Baseline and two weeks after completion of the intervention
|
|
Change in Coughing/Sneezing Hygiene Skill Score
Time Frame: Baseline and two weeks after completion of the intervention
|
Children's coughing/sneezing hygiene skills were assessed using the Coughing/Sneezing Skill Checklist developed by the researchers.
The checklist evaluates appropriate protective behaviors during coughing or sneezing.
Items are scored as "performed" = 2 points, "partially performed" = 1 point, and "not performed" = 0 points.
Higher scores indicate better coughing/sneezing hygiene skills.
Skill performances were video-recorded and evaluated by two independent experts.
|
Baseline and two weeks after completion of the intervention
|
|
Change in Hand Hygiene Skill Score
Time Frame: Baseline and two weeks after completion of the intervention
|
Children's hand hygiene skills were assessed using the Hand Hygiene Skill Checklist developed by the researchers.
The checklist consists of 12 items.
Each item is scored as "performed" = 2 points, "partially performed" = 1 point, and "not performed" = 0 points.
Higher scores indicate better hand hygiene skills.
Children demonstrated handwashing behavior using a standardized handwashing station, and performances were video-recorded and evaluated by two independent experts.
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Baseline and two weeks after completion of the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Parent-Rated Independent Performance of Preventive Behaviors
Time Frame: Baseline and four weeks after completion of the intervention
|
Parents evaluated children's independent performance of preventive behaviors against acute respiratory tract infections using a visual analog scale.
Higher scores indicate a higher level of independent performance of preventive behaviors.
|
Baseline and four weeks after completion of the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aynur Aytekin Özdemir, Professor, Istanbul Medeniyet University
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 1, 2025
Primary Completion (Actual)
January 16, 2026
Study Completion (Actual)
January 16, 2026
Study Registration Dates
First Submitted
June 12, 2026
First Submitted That Met QC Criteria
June 12, 2026
First Posted (Actual)
June 17, 2026
Study Record Updates
Last Update Posted (Actual)
June 17, 2026
Last Update Submitted That Met QC Criteria
June 12, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared due to the involvement of child participants and confidentiality restrictions.
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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