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The Association of Hand Hygiene Practice on Primary Schoolgirls Absence Due to URIs in Riyadh City, 2017-2018.

Primary Purpose

Upper Respiratory Tract Infections

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Hand Hygiene Workshop
Sponsored by
Abrar Alzaher
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Upper Respiratory Tract Infections focused on measuring HAND HYGIENE, HAND WASHING, INFLUENZA, SCHOOL ABSENCE, SCHOOL CHILDREN, UPPER RESPIRATORY INFECTIONS

Eligibility Criteria

6 Years - 12 Years (Child)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All schoolgirls attended randomly selected schools

Exclusion Criteria:

  • None

Sites / Locations

  • Ministry of Education

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Schools received hand hygiene workshop

Schools with did not receive hand hygiene workshop

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Primary schoolgirls absence due to URIs
Absence was collected from schools and parents were called to fill follow up questionnaire

Secondary Outcome Measures

Total Primary schoolgirls absence
Absence was collected from schools

Full Information

First Posted
May 12, 2018
Last Updated
February 28, 2019
Sponsor
Abrar Alzaher
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1. Study Identification

Unique Protocol Identification Number
NCT03535064
Brief Title
The Association of Hand Hygiene Practice on Primary Schoolgirls Absence Due to URIs in Riyadh City, 2017-2018.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 28, 2018 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abrar Alzaher

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections
Keywords
HAND HYGIENE, HAND WASHING, INFLUENZA, SCHOOL ABSENCE, SCHOOL CHILDREN, UPPER RESPIRATORY INFECTIONS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
496 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Schools received hand hygiene workshop
Arm Type
Experimental
Arm Description
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.
Arm Title
Schools with did not receive hand hygiene workshop
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hand Hygiene Workshop
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary schoolgirls absence due to URIs
Description
Absence was collected from schools and parents were called to fill follow up questionnaire
Time Frame
five weeks
Secondary Outcome Measure Information:
Title
Total Primary schoolgirls absence
Description
Absence was collected from schools
Time Frame
five weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All schoolgirls attended randomly selected schools Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abrar A Alzaher, MD
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ministry of Education
City
Riyadh
ZIP/Postal Code
11472
Country
Saudi Arabia

12. IPD Sharing Statement

Learn more about this trial

The Association of Hand Hygiene Practice on Primary Schoolgirls Absence Due to URIs in Riyadh City, 2017-2018.

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