Virtual Reality for Pain Management During Dupilumab Injection
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 6 Years - 17 Years |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06182436 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
St. Justine's Hospital |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Sylvie Le May, PhD |
Principal Investigator Affiliation | St. Justine's Hospital |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Not yet recruiting |
Countries | Canada |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Atopic Dermatitis, Pain, Anxiety |
Contact a Trial Team
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