RecruitingNot ApplicableNCT06182436

Virtual Reality for Pain Management During Dupilumab Injection

Use of Virtual Reality to Improve Pain and Anxiety Management of Children During Dupilumab Injection for Atopic Dermatitis (VR-DERMA)


Sponsor

St. Justine's Hospital

Enrollment

98 participants

Start Date

May 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using a virtual reality (VR) headset during dupilumab injections reduces pain and anxiety in children with atopic dermatitis (a chronic, itchy skin condition). Dupilumab is a biologic medication given by injection under the skin every few weeks. Many children find these injections painful and distressing — the VR experience is designed to distract them and make the process easier. **You may be eligible if...** - Your child is between 6 and 17 years old - Your child has moderate to severe atopic dermatitis and is receiving (or about to start) dupilumab injections - A parent or guardian is present who can read and understand French or English **You may NOT be eligible if...** - Your child has a cognitive impairment preventing them from using the VR headset - Your child has epilepsy or a seizure disorder - Your child has a vision problem that makes wearing a VR headset unsafe - Your child has a condition affecting hand movement needed to interact with the device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVirtual 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.

OTHERStandard 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


Locations(2)

St. Justine's Hospital

Montreal, Quebec, Canada

CHU Sainte-Justine

Montreal, Quebec, Canada

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NCT06182436


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