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
Qualifiers
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
Treatments tested in this trial
- Virtual Reality Distraction
- Standard Treatment
Treatment groups
98 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov