- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07654712
Effectiveness of Education on Preventive Measures Against Acute Respiratory Tract Infections in School-Age Children
12 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
48
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Istanbul
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Istanbul, Istanbul, Turchia (Türkiye)
- Istanbul Medeniyet University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Sì
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
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Nessun intervento: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Knowledge Score on Preventive Measures Against Respiratory Tract Infections
Lasso di tempo: Baseline and two weeks after completion of the intervention
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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.
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Baseline and two weeks after completion of the intervention
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Change in Coughing/Sneezing Hygiene Skill Score
Lasso di tempo: Baseline and two weeks after completion of the intervention
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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.
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Baseline and two weeks after completion of the intervention
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Change in Hand Hygiene Skill Score
Lasso di tempo: Baseline and two weeks after completion of the intervention
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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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Parent-Rated Independent Performance of Preventive Behaviors
Lasso di tempo: Baseline and four weeks after completion of the intervention
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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.
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Baseline and four weeks after completion of the intervention
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Aynur Aytekin Özdemir, Professor, Istanbul Medeniyet University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 novembre 2025
Completamento primario (Effettivo)
16 gennaio 2026
Completamento dello studio (Effettivo)
16 gennaio 2026
Date di iscrizione allo studio
Primo inviato
12 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
12 giugno 2026
Primo Inserito (Effettivo)
17 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025/11
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
Individual participant data will not be shared due to the involvement of child participants and confidentiality restrictions.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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