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Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections

NCT ID: NCT01728090

Last Updated: 2012-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-05-31

Brief Summary

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The aim of the study was to assess the effectiveness of a hand-washing programme using hand sanitizer in the prevention of school absenteeism due to upper respiratory infections. Students in intervention classrooms used hand sanitizers at schools and a programme educational on hand hygiene. The investigators hypothesize that the use de hand sanitizers in elementary school will reduce absenteeism due to upper respiratory infections.

Detailed Description

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School absenteeism due to respiratory infections is one of the greatest problems in schools. Its high incidence and easy transmission among pupils have a great impact requiring a vast number of medical visits, hospitalisations, use of antibiotic and antipyretic treatments, symptomatic medication, etc. besides being a cause for school absenteeism and time off work for parents. Hand- washing is the most important and effective measure to prevent the transmission of infections. The investigators evaluated the effectiveness of a hand-washing programme using hand sanitizer in the prevention of school absenteeism due to upper respiratory infections.

A cluster randomised, controlled and open study of 2 cohorts of primary school children between the ages of 4 and 12, attending 5 Public Schools in a geographic area of the Almería province (Spain). This study was carried out throughout the 8 months of an academic year (October 2009 to May 2010). The experimental group washed their hands with soap and water, complemented with hand sanitizer, while the control group followed usual hand washing. The parents of both groups completed the survey on sociodemographic characteristics and questions about hand hygiene referred to when and how their children wash their hands Progenitors of children who were absent from school collected upper respiratory infections symptoms and handed in the completed form to the teacher. One Research assistant collected the absence sheets of the participating classes weekly, telephoned the parents of absent children to enquire about the cause of their absence, visited the classrooms and collaborated with the teachers in hand hygiene related activities.

Conditions

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Upper Respiratory Infections Influenza Common Cold

Keywords

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handwashing hand sanitizer absenteeism school age children preschool children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hand sanitizer

Intervention classrooms received alcohol-based hand sanitizer and a programme educational.

Characteristics of the hydroalcoholic gel (ALCO ALOE GEL): chlorhexidine digluconate at 20% solution, phenoxyethanol 1%, benzalkonium chloride 0.%. aloe Barbadensis 5%, Renat ethyl alcohol 70%, excipients c.s.p. 100 ml. Alcohol of between 65 - 70% degrees, pondus Hydrogenium (pH) = 7-7,5.

Group Type EXPERIMENTAL

hand sanitizer

Intervention Type OTHER

alcohol-based, hydroalcoholic gel

Control

No hand sanitizer or educational programme were used

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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hand sanitizer

alcohol-based, hydroalcoholic gel

Intervention Type OTHER

Other Intervention Names

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ALCO ALOE GEL

Eligibility Criteria

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Inclusion Criteria

* School children between the ages of 4 and 12 years old, enrolled in the above mentioned public schools,
* The parents/tutors signed an agreement after being informed of its content.

Exclusion Criteria

* Children with absenteeism due to a different cause from upper respiratory infections
* Children with chronic illnesses that could affect their likelihood of contracting an infection or the duration of their period of absence from school
* Children whose parents did not authorise their participation in the study.
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Spain

OTHER_GOV

Sponsor Role collaborator

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

OTHER

Sponsor Role lead

Responsible Party

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Ernestina Azor Martínez

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ernestina Azor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Health of Andalusia

Other Identifiers

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PI 0388/2008

Identifier Type: -

Identifier Source: org_study_id