NCT03535064

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
496

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 1, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

May 12, 2018

Last Update Submit

February 28, 2019

Conditions

Keywords

HAND HYGIENE, HAND WASHING, INFLUENZA, SCHOOL ABSENCE, SCHOOL CHILDREN, UPPER RESPIRATORY INFECTIONS

Outcome Measures

Primary Outcomes (1)

  • Primary schoolgirls absence due to URIs

    Absence was collected from schools and parents were called to fill follow up questionnaire

    five weeks

Secondary Outcomes (1)

  • Total Primary schoolgirls absence

    five weeks

Study Arms (2)

Schools received hand hygiene workshop

EXPERIMENTAL

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.

Other: Hand Hygiene Workshop

Schools with did not receive hand hygiene workshop

NO INTERVENTION

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.

Interventions

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.

Schools received hand hygiene workshop

Eligibility Criteria

Age6 Years - 12 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All schoolgirls attended randomly selected schools

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Education

Riyadh, 11472, Saudi Arabia

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsInfluenza, Human

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesOrthomyxoviridae InfectionsRNA Virus InfectionsVirus Diseases

Study Officials

  • Abrar A Alzaher, MD

    King Saud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2018

First Posted

May 24, 2018

Study Start

January 28, 2018

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

March 1, 2019

Record last verified: 2019-02

Locations