Clinical trial NCT03535064: 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
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infections
Keywords: HAND HYGIENE, HAND WASHING, INFLUENZA, SCHOOL ABSENCE, SCHOOL CHILDREN, UPPER RESPIRATORY INFECTIONS
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 496
Sex: FEMALE
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* All schoolgirls attended randomly selected schools

Exclusion Criteria:

* None

Primary outcomes:
measure: Primary schoolgirls absence due to URIs
timeFrame: five weeks
Secondary outcomes:
measure: Total Primary schoolgirls absence
timeFrame: five weeks
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Ministry of Education
Study officials:
affiliation: King Saud University
name: Abrar A Alzaher, MD
role: PRINCIPAL_INVESTIGATOR
References: