- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07654712
Effectiveness of Education on Preventive Measures Against Acute Respiratory Tract Infections in School-Age Children
12 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
48
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Istanbul
-
Istanbul, Istanbul, Turkiet (Türkiye)
- Istanbul Medeniyet University
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
|
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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Knowledge Score on Preventive Measures Against Respiratory Tract Infections
Tidsram: 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.
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Baseline and two weeks after completion of the intervention
|
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Change in Coughing/Sneezing Hygiene Skill Score
Tidsram: 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
|
|
Change in Hand Hygiene Skill Score
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Parent-Rated Independent Performance of Preventive Behaviors
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Aynur Aytekin Özdemir, Professor, Istanbul Medeniyet University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 november 2025
Primärt slutförande (Faktisk)
16 januari 2026
Avslutad studie (Faktisk)
16 januari 2026
Studieregistreringsdatum
Först inskickad
12 juni 2026
Först inskickad som uppfyllde QC-kriterierna
12 juni 2026
Första postat (Faktisk)
17 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025/11
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Individual participant data will not be shared due to the involvement of child participants and confidentiality restrictions.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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