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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
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 belowSelect...
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).
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 moreTrial 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
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Who is running the clinical trial?
St. Justine's HospitalLead Sponsor
198 Previous Clinical Trials
84,142 Total Patients Enrolled
10 Trials studying Anxiety
682 Patients Enrolled for Anxiety
Sylvie Le May, PhDPrincipal InvestigatorSt. Justine's Hospital
13 Previous Clinical Trials
1,403 Total Patients Enrolled
6 Trials studying Anxiety
422 Patients Enrolled for Anxiety
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