Virtual Reality for Pain Management During Dupilumab Injection

NCT06182436 | Recruiting

• 1 other identifier: VR-DERMA
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

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. 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. 2.Does the occurence of side effects is similar between both study groups?

Conditions

Atopic Dermatitis; Pain; Anxiety

Outcome Measures

Primary Outcomes (2)

• mean difference in pain intensity score between sequences

  Pain intensity will be assessed using the Numerical Rating Scale (NRS) for children 6 years and older. The NRS is an 11-item scale for pain intensity ranging from 0 to 10; 0=no pain to 10= worst pain ever felt.

  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

  The level of anxiety will be assessed using the Child Fear Scale (CFS). It consists of five faces ranging from 0 (no fear/anxiety) through 4 (extremely fearful/anxious). The child is asked to indicate which face shows best how he/she felt during the procedure.

  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).

Secondary Outcomes (5)

• 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

  Reported immediately after the procedure on day 1 and a week later on day 2 (T2 and T4)

• children's satisfaction levels

  Reported immediately after the procedure on day 1 and a week later on day 2 (T2 and T4)

• healthcare professionals' satisfaction levels

  Reported immediately after the sequence, a week later on day 2 (T4)

• Occurrence of adverse events

  Reported immediately after the procedure on day 1 and a week later on day 2 (T2 and T4)

• parents' satisfaction levels

  Reported immediately after the sequence a week later on day 2 (T4)

Study Arms (2)

Virtual Reality Distraction

EXPERIMENTAL

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

Device: Virtual Reality Distraction

Standard Treatment

ACTIVE COMPARATOR

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

Other: Standard Treatment

Interventions

Virtual Reality Distraction DEVICE

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.

Virtual Reality Distraction

Standard Treatment OTHER

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

Standard Treatment

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• between the ages of 6 to 17 years old,
• suffering from moderate to severe atopic dermatitis and receiving or about to start subcutaneous injections of dupilumab,
• in the presence of a consenting parent who can understand, read, and write either French or English.

You may not qualify if:

• have a diagnosed cognitive impairment precluding them from playing a virtual reality game,
• suffer from epilepsy considering the nature of the intervention,
• 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.

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (2)

St. Justine's Hospital

Montreal, Quebec, H1T 3C5, Canada

RECRUITING

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

Dermatitis, Atopic; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Sylvie Le May, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie Le May, PhD

CONTACT

5143454931; sylvie.lemay@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Every patient (98) will be their own control (98+98=196). Allocation to either intervention or control will be randomized at first then switched at the crossover period.

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: December 27, 2023
• Study Start: May 16, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)