NCT06182436 Virtual Reality for Pain Management During Dupilumab Injection
| NCT ID | NCT06182436 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Justine's Hospital |
| Condition | Atopic Dermatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2024-05-16 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 98 participants in total. It began in 2024-05-16 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. between the ages of 6 to 17 years old, 2. suffering from moderate to severe atopic dermatitis and receiving or about to start subcutaneous injections of dupilumab, 3. in the presence of a consenting parent who can understand, read, and write either French or English. Exclusion Criteria: 1. have a diagnosed cognitive impairment precluding them from playing a virtual reality game, 2. suffer from epilepsy considering the nature of the intervention, 3. 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.
Contact & Investigator
Sylvie Le May, PhD
PRINCIPAL INVESTIGATOR
St. Justine's Hospital
Frequently Asked Questions
Who can join the NCT06182436 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Atopic Dermatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06182436 currently recruiting?
Yes, NCT06182436 is actively recruiting participants. Contact the research team at sylvie.lemay@umontreal.ca for enrollment information.
Where is the NCT06182436 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT06182436 clinical trial?
NCT06182436 is sponsored by St. Justine's Hospital. The principal investigator is Sylvie Le May, PhD at St. Justine's Hospital. The trial plans to enroll 98 participants.
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