Cluster-RCT Collective Nasopharyngeal COVID-19 Testing Amongst Pupils

Parents Clinical Trial

Official title:

Peers' and Parent's Presence During Collective Nasopharyngeal COVID-19 Testing Amongst Pupils: A Cluster-Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04993547
• Other study ID #: BAD/DV/2021/BC-09709
• Secondary ID: BUN6702021000301
• Status: Completed
• Phase: N/A
• Start date: March 31, 2021
• Est. completion date: June 10, 2021

Study information

• Verified date: March 2021
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?

Description:

In order to control the outbreak of cluster infections on school during the COVID-19 pandemic, regular rounds of collective nasopharyngeal swab testing were organized. However, it is unclear under which circumstances nasopharyngeal swab testing is better accepted by young children. Due to the closing of schools, and the different logistic situations in schools, a natural pragmatic RCT formed. In some cases, children could observe their peers before having their own test, while for others the view was blocked. Also, sometimes parents would be present during a test procedure when the school was closed, while they were not present when the school was open. To date, it is unclear whether these two variable elements influence a child's resistance to be tested. Therefore a cluster-randomized controlled trial with testing site as the unit of randomisation will be set-up. Four conditions will be tested. On the individual level, the resistance of their peers before their own testing will be taken into account. The aim of the study is to compare whether (1) the visibility of nasopharyngeal swab testing on their peers and (2) the presence of their parents impacts a child's resistance towards the test. Additionally, the impact of whether or not their peers resisted the test impact predicts the likelihood of their own resisting behaviour.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 952
• Est. completion date: June 10, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Months to 12 Years

Eligibility

Inclusion Criteria:

• undergoing a nasopharyngeal COVID-19 swab test Exclusion Criteria: -

Related Conditions & MeSH terms

• Parents
• Peer Group

Intervention

Other:
• Parent and peer presence
Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	test resistance	resistance for swab testing	1 day