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Anxiety

Virtual Reality for Pain Management During Dupilumab Injection

Recruiting · Montreal, Quebec

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Voluntary — you can stop anytime

What is this study?

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.

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

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.

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

  • Children ages 6 to 17
  • Children with moderate to severe atopic dermatitis who are receiving or about to start subcutaneous dupilumab injections
  • A parent/guardian must consent and be able to understand, read, and write French or English

🚫 You may not be able to join if…

  • Children with cognitive impairment that would prevent them from playing the VR game
  • Children who have epilepsy
  • Children who cannot sit during the procedure (the VR game needs head-tracking with the person at an angle of at least 30 degrees)

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

  • Adults roughly 6–17

What to expect, step by step

  1. 1

    Usually a few weeks

    The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.

  2. 2

    Treatment

    If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.

  3. 3

    Follow-up

    After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

The study team can share what safety testing has been done so far.

What you need to know before you apply

What is this study testing?+

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.

Is it safe? Who makes sure of that?+

This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Source: ClinicalTrials.gov · NCT06182436 · Locations: Quebec