- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07654712
Effectiveness of Education on Preventive Measures Against Acute Respiratory Tract Infections in School-Age Children
12 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Real)
48
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Istanbul
-
Istanbul, Istanbul, Turquia (Türkiye)
- Istanbul Medeniyet University
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
|
Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Knowledge Score on Preventive Measures Against Respiratory Tract Infections
Prazo: 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
Prazo: 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
Prazo: 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.
|
Baseline and two weeks after completion of the intervention
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Parent-Rated Independent Performance of Preventive Behaviors
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Aynur Aytekin Özdemir, Professor, Istanbul Medeniyet University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de novembro de 2025
Conclusão Primária (Real)
16 de janeiro de 2026
Conclusão do estudo (Real)
16 de janeiro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
12 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de junho de 2026
Primeira postagem (Real)
17 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025/11
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data will not be shared due to the involvement of child participants and confidentiality restrictions.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .