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

Inclusion Criteria3

  • between the ages of 6 to 17 years old,
  • suffering from moderate to severe atopic dermatitis and receiving or about to start subcutaneous injections of dupilumab,
  • in the presence of a consenting parent who can understand, read, and write either French or English.

Exclusion Criteria3

  • have a diagnosed cognitive impairment precluding them from playing a virtual reality game,
  • suffer from epilepsy considering the nature of the intervention,
  • cannot be in a sitting position during the procedure as the virtual reality game requires an angle of at least 30 degrees for head-tracking.

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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