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

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ClinicalTrials.gov Identifier: NCT01728090
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : November 19, 2012
Sponsor:
Collaborator:
Ministry of Health, Spain
Information provided by (Responsible Party):
Ernestina Azor Martínez, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Upper Respiratory Infections Influenza Common Cold Other: hand sanitizer Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of a Handwashing Programme in the Prevention of School Absenteeism Due to Respiratory Infections
Study Start Date : October 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


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 Name: ALCO ALOE GEL

No Intervention: Control
No hand sanitizer or educational programme were used



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728090


Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Ministry of Health, Spain
Investigators
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Principal Investigator: Ernestina Azor, MD, PhD Department of Health of Andalusia

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Responsible Party: Ernestina Azor Martínez, MD, PhD, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
ClinicalTrials.gov Identifier: NCT01728090     History of Changes
Other Study ID Numbers: PI 0388/2008
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: November 19, 2012
Last Verified: November 2012
Keywords provided by Ernestina Azor Martínez, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental:
handwashing
hand sanitizer
absenteeism
school age children
preschool children
Additional relevant MeSH terms:
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RNA Virus Infections
Virus Diseases
Infection
Communicable Diseases
Respiratory Tract Infections
Common Cold
Respiratory Tract Diseases
Picornaviridae Infections
Hand Sanitizers
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants