Virtual Reality for Pain Management During Eczema Treatment

(VR-DERMA Trial)

Overseen By Sylvie Le May, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Must be taking: Dupilumab

Disqualifiers: Cognitive impairment, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

98 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sylvie Le May, PhD

Principal Investigator

St. Justine's Hospital

Eligibility Criteria

This trial is for children aged 6 to 17 with moderate to severe atopic dermatitis who need dupilumab injections. It's designed to see if playing a VR game during the injection can help manage pain and anxiety compared to standard treatment without specific distraction.

Inclusion Criteria

I have moderate to severe eczema and am taking or starting dupilumab injections.

I am between 6 and 17 years old.

My parent or guardian understands and can communicate in English or French.

Exclusion Criteria

I can't sit up straight during the procedure as it needs me to tilt my head.

Have a diagnosed cognitive impairment precluding them from playing a virtual reality game

I have epilepsy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injections of dupilumab with either VR distraction or standard care in a randomized order

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• Virtual Reality Distraction

Trial Overview The study tests whether using Virtual Reality (VR) games as a distraction reduces pain and anxiety more effectively than standard care during dupilumab injections in children. Participants will experience both methods, one with VR and one without, in random order.

Participant Groups

Group I: Virtual Reality Distraction Experimental Treatment 1 Intervention

The child will play with the VR device for five minutes prior to the subcutaneous injection.

Group II: Standard Treatment Active Control 1 Intervention

Standard care consisting of injecting dupilumab subcutaneously without any distractive measure, with the child having full knowledge of the intervention

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+