NCT04993547

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
952

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
Last Updated

August 6, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

August 4, 2021

Last Update Submit

August 5, 2021

Conditions

Peer GroupParents

Keywords

Public HealthPediatricNasopharyngealCollective testing

Outcome Measures

Primary Outcomes (1)

  • test resistance

    resistance for swab testing

    1 day

Study Arms (4)

Parents present, peers present

EXPERIMENTAL

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.

Other: Parent and peer presence

Parent present, peers absent

ACTIVE COMPARATOR

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.

Other: Parent and peer presence

Parents absent, peers present

ACTIVE COMPARATOR

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.

Other: Parent and peer presence

Parents absent, peers absent

ACTIVE COMPARATOR

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.

Other: Parent and peer presence

Interventions

Parent and peer presenceOTHER

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

Parent present, peers absentParents absent, peers absentParents absent, peers presentParents present, peers present

Eligibility Criteria

Age30 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • undergoing a nasopharyngeal COVID-19 swab test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Study Officials

  • Simon Malfait

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2021

First Posted

August 6, 2021

Study Start

March 31, 2021

Primary Completion

June 9, 2021

Study Completion

June 10, 2021

Last Updated

August 6, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)