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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
First received
Last updated
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
Health authority
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: -

Study Design


Related Conditions & MeSH terms


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
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