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Behavioural Intervention

Virtual Reality for Pain Management During Eczema Treatment (VR-DERMA Trial)

N/A

Waitlist Available

Led By Sylvie Le May, PhD

Research Sponsored by St. Justine's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Suffering from moderate to severe atopic dermatitis and receiving or about to start subcutaneous injections of dupilumab

Between the ages of 6 to 17 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up reported immediately after the sequence, a week later on day 2 (t4)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a virtual reality game can help reduce pain and anxiety in children receiving a specific injection for a skin condition. Children between 6 and 17 years old will be recruited for

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not directly related to side effects of the drug itself, this trial assesses discomfort from injections. Potential side effects may include typical reactions to subcutaneous shots like redness or swelling at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am between 6 and 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after the procedure on day 1 and a week later on day 2 (t2 and t4) (self-report of anxiety levels during the procedure).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after the procedure on day 1 and a week later on day 2 (t2 and t4) (self-report of anxiety levels during the procedure).

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the procedure on day 1 and a week later on day 2 (t2 and t4) (self-report of anxiety levels during the procedure). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

mean difference in anxiety between sequences

mean difference in pain intensity score between sequences

Secondary study objectives

Mean difference in cognitive, affective and sensory components of pain as well as sense of presence in VR and engagement into the game between groups

Occurrence of adverse events

children's satisfaction levels

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Reality DistractionExperimental Treatment1 Intervention

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

Group II: Standard TreatmentActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual Reality Distraction

2016

Completed Phase 3

~740

0 / 2Eligibility criteria met