Cluster-RCT Collective Nasopharyngeal COVID-19 Testing Amongst Pupils

Ghent University Hospital (UZ)

Status: Completed

Conditions: Parents; Peer Group

Treatments: Other: Parent and peer presence

Study type: Interventional

Funder types: Other

Identifiers

NCT04993547

BAD/DV/2021/BC-09709

BUN6702021000301 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 952 patients

Sex: All

Ages: 30 months to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• undergoing a nasopharyngeal COVID-19 swab test

Exclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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952 participants in 4 patient groups

Parents present, peers present

Experimental group

Description:

The children are accompanied by their parents during the COVID-19 testing, and a visible covid-19 swab test waiting line is set-up enabling the children to observe their peers being tested.

Treatment:

Other: Parent and peer presence

Parent present, peers absent

Active Comparator group

Description:

The children are also accompanied by their parents, but a covered COVID-19 swab test waiting line is set-up whereby the children are unable to observe their peers being tested.

Treatment:

Other: Parent and peer presence

Parents absent, peers present

Active Comparator group

Description:

Parents are absent during the COVID-19 testing, and a visible COVID-19 swab test waiting line is set-up enabling the children to observe their peers being tested.

Treatment:

Other: Parent and peer presence

Parents absent, peers absent

Active Comparator group

Description:

Parents are absent, and a covered COVID-19 swab test waiting line is set-up whereby the children are not able to observe their peers being tested.

Treatment:

Other: Parent and peer presence