Virtual Reality for Pain Management During Dupilumab Injection

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• mean difference in pain intensity score between sequences — 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).
  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.
• mean difference in anxiety between sequences — 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).
  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.

Trial sites (2)

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