Clinical Trial

Virtual Reality for Pain Management During Dupilumab Injection

Study acronym: VR-DERMA
Recruiting
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Summary
The aim of this within-subject randomized study is to examine the efficacy of a VR immersive game for pain and anxiety management of children during the subcutaneous injection of dupilumab for moderate to severe atopic dermatitis. We will recruit children from 6 to 17 years. The main research question is: 1. Does VR immersive game will generate less anxiety and pain than standard procedures, for children receiving dupilumab injection for moderate to severe atopic dermatitis? 2. Does the occurence of side effects is similar between both study groups? Participants will be randomized according to either sequences: VR-Standard care or Standard care-VR. During the VR sequence, participants will be playing the VR immersive game during the injection. During the Standard care sequence participants will not benefit from any pain management but passive distraction tools will be offered (and documented) to children. The investigators will take measures of pain and anxiety, using validated scales, before and after the procedures at each sequence.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-12-12.
Status change: Not Yet Recruiting → Recruiting 2025-08-18
Trial Details
NCT Number NCT06182436
Lead Sponsor St. Justine's Hospital
Conditions Atopic Dermatitis, Pain, Anxiety
Enrollment 98 participants
Start Date 2024-05-16
Primary Completion 2027-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2025-08-24