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

November 16, 2012 updated by: Ernestina Azor Martínez, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

1640

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: hand sanitizer
alcohol-based, hydroalcoholic gel
Other Names:
  • ALCO ALOE GEL
No Intervention: Control
No hand sanitizer or educational programme were used

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
School absenteeism rate caused by upper respiratory infection
Time Frame: One academic year (eight months follow-up)

The incidence rate of respiratory infections was calculated dividing the number of episodes respiratory by the number of pupils during the period of this study who were susceptible to the infection.

Incidence rate ratio indicates (IRR): the ratio between incidence rate in both study groups.
One academic year (eight months follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average duration of absence
Time Frame: One academic year (eight months follow-up)
The average duration of absence per child was calculated dividing the number of absence days due to respiratory infection by the total number of children during that period.
One academic year (eight months follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

Collaborators

Ministry of Health, Spain

Investigators

  • Principal Investigator: Ernestina Azor, MD, PhD, Department of Health of Andalusia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

November 13, 2012

First Submitted That Met QC Criteria

November 15, 2012

First Posted (Estimate)

November 16, 2012

Study Record Updates

Last Update Posted (Estimate)

November 19, 2012

Last Update Submitted That Met QC Criteria

November 16, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI 0388/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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