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Virtual Reality for Pain Management During Dupilumab Injection

NCT06182436 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-08-24

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Virtual Reality Distraction

For the experimental treatment, the child will play with the VR device for five minutes prior to the subcutaneous injection to reduce pain. The VR game Dream and the Pico Neo 4 VR headset were designed by Paperplane Therapeutics for the pediatric population. Participants will be able to direct laser beams at magical elements such as trolls and crystals. Since it is a no-success game, participants can enjoy it regardless of their past video game experience.

OTHER

Standard Treatment

Standard care consisting of injecting dupilumab subcutaneously without any distractive measure, with the child having full knowledge of the intervention. Use of any co-interventions for pain management (music, comforting, child life specialist or other) during this sequence will be documented

Sponsors & Collaborators

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Sylvie Le May, PhD · St. Justine's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-16
Primary Completion
2027-01-31
Completion
2028-01-31

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06182436 on ClinicalTrials.gov