NCT07654712

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 12, 2026

Last Update Submit

June 12, 2026

Conditions

Keywords

Acute respiratory tract infectionsRespiratory hygieneHand hygieneSchool healthPrimary school childrenHealth educationCluster randomized controlled trial

Outcome Measures

Primary Outcomes (3)

  • Change in Knowledge Score on Preventive Measures Against Respiratory Tract Infections

    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

    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

    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.

    Baseline and two weeks after completion of the intervention

Secondary Outcomes (1)

  • Change in Parent-Rated Independent Performance of Preventive Behaviors

    Baseline and four weeks after completion of the intervention

Study Arms (2)

Animation Video-Supported Education Group

EXPERIMENTAL

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.

Behavioral: Animation Video-Supported Education on Preventive Measures Against Acute Respiratory Tract Infections

Control Group

NO INTERVENTION

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.

Interventions

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.

Animation Video-Supported Education Group

Eligibility Criteria

Age6 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Aynur Aytekin Özdemir, Professor

    İstanbul Medeniyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the educational intervention, participants and the researcher delivering the intervention could not be blinded. However, skill performances were video-recorded and evaluated by two independent experts.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 17, 2026

Study Start

November 1, 2025

Primary Completion

January 16, 2026

Study Completion

January 16, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to the involvement of child participants and confidentiality restrictions.

Locations