Recruiting

VR Immersive Game

Sponsor:

St. Justine's Hospital

Code:

NCT06182436

Conditions

Atopic Dermatitis

Pain

Anxiety

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Virtual Reality Distraction

Standard Treatment

Study Details

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.

Conditions

Atopic Dermatitis

Pain

Anxiety

Study ID

NCT06182436

Start date

May 16, 2024

Status verified date

Aug, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Virtual Reality Distraction

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

active comparator: Standard Treatment

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

Interventions

Virtual Reality Distraction

For the experimental treatment, the child will play with the VR device for five minutes prior to the subcutaneous injection to reduce pain. The VR game Dream and the Pico Neo 4 VR headset were designed by Paperplane Therapeutics for the pediatric population. Participants will be able to direct laser beams at magical elements such as trolls and crystals. Since it is a no-success game, participants can enjoy it regardless of their past video game experience.

Standard Treatment

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

Use of any co-interventions for pain management (music, comforting, child life specialist or other) during this sequence will be documented

Primary outcome measure

  • mean difference in pain intensity score between sequences [ Time Frame: Immediately after the procedure on day 1 and a week later on day 2 (T2 and T4) (self-report of pain levels during the procedure). ]
  • mean difference in anxiety between sequences [ Time Frame: 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). ]

Central Contacts and Locations

Central contacts

Sylvie Le May, PhD

5143454931sylvie.lemay@umontreal.ca

Locations

St. Justine's Hospital

Recruiting

Montreal, Quebec, Canada, H1T 3C5

Contacts

Sylvie Le May, PhD

5143454931sylvie.lemay@umontreal.ca

Principal Investigator:

Sylvie Le May, PhD

CHU Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Sylvie Le May, RN, PhD, FCAN

5143454931sylvie.lemay@umontreal.ca

More Information

Sponsor

St. Justine's Hospital

Last update posted

Aug 24, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2025-08-24.