Virtual reality game to reduce pain and anxiety during dupilumab injections

Use of Virtual Reality to Improve Pain and Anxiety Management of Children During Dupilumab Injection for Atopic Dermatitis (VR-DERMA)

This project will test whether a virtual reality game can reduce pain and anxiety for children aged 6–17 during dupilumab injections for moderate to severe atopic dermatitis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: St. Justine's Hospital (other)
• Drugs / interventions: dupilumab
• Locations: 2 sites (Montreal, Quebec and 1 other locations)
• Trial ID: NCT06182436 on ClinicalTrials.gov

What this trial studies

This within-subject randomized crossover study enrolls children aged 6–17 receiving subcutaneous dupilumab for moderate to severe atopic dermatitis and compares an immersive VR game to standard care during injections. Participants are randomized to receive VR during the first injection and standard care during the second, or vice versa, with passive distraction tools allowed and documented in the standard care visits. Pain and anxiety are measured with validated scales around the injection and adverse events are recorded to compare side-effect rates between conditions. Sessions take place at CHU Sainte-Justine in Montreal and children with cognitive impairment, epilepsy, or unable to sit upright are excluded.

Who should consider this trial

Good fit: Children aged 6–17 with moderate to severe atopic dermatitis who are receiving or about to start subcutaneous dupilumab and have a parent able to consent in English or French.

Not a fit: Children with cognitive impairment preventing VR use, a history of epilepsy, or who cannot sit upright during the procedure are excluded and unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the VR game could make injections less painful and stressful for children and improve their injection experience and treatment adherence.

How similar studies have performed: A small number of VR studies in pediatric burn patients have shown reduced procedural pain, but applying VR to dupilumab injections is relatively novel and not well studied.

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.

Where this trial is running

Montreal, Quebec and 1 other locations

• St. Justine's Hospital — Montreal, Quebec, Canada (RECRUITING)
• CHU Sainte-Justine — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Sylvie Le May, PhD — St. Justine's Hospital
• Study coordinator: Sylvie Le May, PhD

Conditions: Atopic Dermatitis, Pain, Anxiety