Virtual Reality for Pain Management During Dupilumab Injection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorSt. Justine's Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Virtual Reality Distraction
DeviceFor 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
Other interventionStandard 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
Treatment groups
98 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality DistractionExperimental treatment 1 intervention
Group B: Standard TreatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
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).2
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.
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).Secondary outcomes
1
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
Assessed using the Graphic Rating Scale (GRS) a 7-item Likert-type scale tailored for virtual reality interventions.
Time frame
Reported immediately after the procedure on day 1 and a week later on day 2 (T2 and T4)2
children's satisfaction levels
Assessed using a 0 to 10 numerical scale to answer the following question as recommended by PedIMMPACT (McGrath et al., 2008): "Considering pain relief, side effects, physical recovery, and emotional recovery, how satisfied were you with the treatments you/your child received for pain?"
Time frame
Reported immediately after the procedure on day 1 and a week later on day 2 (T2 and T4)3
healthcare professionals' satisfaction levels
Healthcare professional's satisfaction level will be assessed using a tailored questionnaire with four choices response scale from Strongly agree to Strongly disagree for 7 items related to their level of satisfaction with the intervention and its effect on the procedure.
Time frame
Reported immediately after the sequence, a week later on day 2 (T4)4
Occurrence of adverse events
Occurrence of adverse events will be assessed and documented from enrolment until discharge.
Time frame
Reported immediately after the procedure on day 1 and a week later on day 2 (T2 and T4)Sponsors and contacts
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Source ClinicalTrials.gov