- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03535064
The Association of Hand Hygiene Practice on Primary Schoolgirls Absence Due to URIs in Riyadh City, 2017-2018.
The Association of Hand Hygiene Practice on Primary Schoolgirls Absence Due to Upper Respiratory Infections (URIs) in Riyadh City, 2017-2018. A Cluster Randomized Trial
Research Problem:
Upper respiratory infections (URIs) are a common reason for absence from schools as it is estimated that children get six to eight episodes every year. In Jazan (2013-2014), 34% of primary health care centre attendees who were complaining of URIs were under 15 years old and 42% of them were positive when tested for viruses by nasopharyngeal swabs. An intervention for URIs prevention is hand hygiene, as it has been shown to have an impact on reducing the risk of respiratory infections by 50% among children in Karachi, Pakistan by encouraging hand washing with soap. Another randomised controlled trial study conducted in Spain among primary school students showed a statistically significant 38% reduction in the absenteeism rate due to URIs in the intervention group who received education about hand hygiene and used hand sanitisers which were distributed among schools. Also, the Chinese conducted a cluster randomised control trial evaluating the effect of a hand washing programme and revealed a 38% reduction in absence due to URIs among primary schoolchildren.
This preventive measure is questionable, as a randomised controlled trial done among primary school students in New Zealand revealed that encouraging the use of hand sanitisers in schools did not have an impact on reducing acute respiratory infections or absenteeism. The questionable effect was also documented in a systematic review and meta-analysis for randomised controlled trials about the effectiveness of hand hygiene in decreasing absences through illness in educational settings.
Research Significance:
Appropriate hand hygiene is recommended as a non-pharmacological preventive measure against respiratory infections. But this preventive measure is questionable as the results of randomised controlled trials about the effectiveness of different hand hygiene interventions in reducing absence due to upper respiratory tract infection in different educational settings are controversial. Furthermore, previous studies of hand hygiene interventions were low in quality and it is recommended to improve future studies relating to it. Also, there is no research on the effectiveness of these measures in Saudi Arabia. So, this piece will add new knowledge to local and international literature. In addition, this study may help the school health administration to develop a hand hygiene programme.
Objectives:
- To determine if hand hygiene education is associated with school absence rates due to URIs reduction among primary schoolgirls in Riyadh city, 2017-2018
- To measure post-intervention total primary schoolgirl's absence rate (both groups) in Riyadh city, 2017-2018.
- To measure post-intervention primary schoolgirls' absence rate due to upper respiratory infections (both groups) in Riyadh city, 2017-2018.
Methodology:
Cluster RCT will be conducted among primary schoolgirls attending public schools in Riyadh city in the first education semester. Sampling will be multistage to end up with four schools. 616 schoolgirls who are attending the selected classes will be invited to the study. Two schools will be randomly assigned to the intervention, which includes one-hour hand washing workshop at the beginning of the study, in addition to posters. Parents will self-administer the questionnaire at baseline, in addition to a follow-up phone interview questionnaire.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
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Riyadh, Arabia Saudita, 11472
- Ministry of Education
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- All schoolgirls attended randomly selected schools
Exclusion Criteria:
- None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Schools received hand hygiene workshop
Schoolgirls of randomly assigned schools attended one-hour Arabic handwashing workshop conducted by the principal investigator one week after submitting all baseline questionnaires.
Workshops included video-clip and interactive lecture about common infections in schools, methods of transmission, and hand washing procedure and time.
Puzzle games related to hand hygiene were distributed among schoolgirls.
Posters with cartoon princess picture promote for hand hygiene were also distributed among the schools.
|
Workshops included video-clip and interactive lecture about common infections in schools, methods of transmission, and hand washing procedure and time.
Puzzle games related to hand hygiene were distributed among schoolgirls.
Posters with cartoon princess picture promote for hand hygiene were also distributed among the schools.
|
Sin intervención: Schools with did not receive hand hygiene workshop
Schoolgirls in control group followed their usual hand washing procedure.
When the study ended, schoolgirls of control school were exposed to the same intervention by the same investigator.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Primary schoolgirls absence due to URIs
Periodo de tiempo: five weeks
|
Absence was collected from schools and parents were called to fill follow up questionnaire
|
five weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Total Primary schoolgirls absence
Periodo de tiempo: five weeks
|
Absence was collected from schools
|
five weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Abrar A Alzaher, MD, King Saud University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- E-17-2523
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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