Actively Recruiting

Phase Not Applicable
Age: 6Years - 17Years
All Genders
NCT06182436

Virtual Reality for Pain Management During Dupilumab Injection

Led by St. Justine's Hospital · Updated on 2025-08-24

98

Participants Needed

2

Research Sites

189 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Virtual Reality for Pain Management During Dupilumab Injection

Who Can Participate

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between the ages of 6 to 17 years old
  • Diagnosed with moderate to severe atopic dermatitis and receiving or about to start subcutaneous dupilumab injections
  • Presence of a consenting parent who understands, reads, and writes French or English
Not Eligible

You will not qualify if you...

  • Diagnosed cognitive impairment that prevents playing a virtual reality game
  • Epilepsy diagnosis
  • Inability to sit during the procedure with at least a 30-degree head angle required for VR use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

St. Justine's Hospital

Montreal, Quebec, Canada, H1T 3C5

Actively Recruiting

2

CHU Sainte-Justine

Montreal, Quebec, Canada, H3T 1C5

Actively Recruiting

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Research Team

S

Sylvie Le May, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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