Virtual Reality for Pain Management During Eczema Treatment

(VR-DERMA Trial)

Recruiting at 2 trial locations

Overseen By Sylvie Le May, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Must be taking: Dupilumab

Disqualifiers: Cognitive impairment, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

98 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a virtual reality (VR) game can reduce pain and anxiety in children receiving injections for moderate to severe eczema (atopic dermatitis). Participants will either play a VR game during their injection or receive standard care, which includes basic distraction techniques. The goal is to determine if VR makes the experience less stressful compared to standard care. Children aged 6 to 17 with moderate to severe eczema who are receiving or about to start injections might be suitable candidates.

As an unphased trial, this study provides a unique opportunity to explore innovative ways to improve the injection experience for children.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using virtual reality to manage pain and anxiety during dupilumab injections for eczema.

What prior data suggests that this VR immersive game is safe for children during eczema treatment?

Studies have shown that virtual reality (VR) is generally safe and well-tolerated for children and teens. One study found that using VR to distract kids during medical procedures reduced pain and anxiety without causing harm. Another study reported that VR was practical and acceptable for children with long-term pain, suggesting it is a promising tool for managing discomfort.

Research indicates that using VR during eczema treatment can effectively distract children from uncomfortable symptoms. This suggests that VR is a safe option for managing anxiety and pain during injections.

In summary, VR appears to be a safe and effective way to help kids feel less scared and hurt during medical treatments, with no major side effects reported in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Virtual Reality (VR) distraction for pain management during eczema treatment because it offers a unique way to reduce discomfort without the need for additional medication. Unlike standard treatments that simply involve administering medication like dupilumab without any distraction, VR provides an immersive experience that can help children focus on something enjoyable instead of the pain from injections. This approach taps into the brain's ability to divert attention, potentially making the treatment experience less stressful and more tolerable for young patients.

What evidence suggests that Virtual Reality Distraction is effective for pain and anxiety management during eczema treatment?

Research has shown that virtual reality (VR) can greatly reduce pain during medical procedures. VR immerses users in a computer-generated world, diverting their attention from the pain. Studies have found that this method lowers both pain and anxiety in children undergoing treatments like injections. In this trial, one group of children will use VR distraction before receiving dupilumab injections for eczema, while another group will receive standard treatment without any distractive measures. These findings suggest that VR could help lessen pain and anxiety for children receiving dupilumab injections for eczema. ^{1 2 5 6 7}

Who Is on the Research Team?

Sylvie Le May, PhD

Principal Investigator

St. Justine's Hospital

Are You a Good Fit for This Trial?

This trial is for children aged 6 to 17 with moderate to severe atopic dermatitis who need dupilumab injections. It's designed to see if playing a VR game during the injection can help manage pain and anxiety compared to standard treatment without specific distraction.

Inclusion Criteria

I have moderate to severe eczema and am taking or starting dupilumab injections.

I am between 6 and 17 years old.

My parent or guardian understands and can communicate in English or French.

Exclusion Criteria

I can't sit up straight during the procedure as it needs me to tilt my head.

Have a diagnosed cognitive impairment precluding them from playing a virtual reality game

I have epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injections of dupilumab with either VR distraction or standard care in a randomized order

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Distraction

Trial Overview The study tests whether using Virtual Reality (VR) games as a distraction reduces pain and anxiety more effectively than standard care during dupilumab injections in children. Participants will experience both methods, one with VR and one without, in random order.

How Is the Trial Designed?

Group I: Virtual Reality Distraction Experimental Treatment 1 Intervention

The child will play with the VR device for five minutes prior to the subcutaneous injection.

Group II: Standard Treatment Active Control 1 Intervention

Standard care consisting of injecting dupilumab subcutaneously without any distractive measure, with the child having full knowledge of the intervention

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2734514/

Effects of virtual reality immersion and audiovisual distraction ... Virtual reality immersion (VRI), an advanced computer-generated technique, decreased subjective reports of pain in experimental and procedural medical ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06182436

Virtual Reality for Pain Management During Dupilumab ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4043365/

Virtual Reality as a Distraction Technique in Chronic Pain ... Positive results of VRH therapy indicate a synergistic and additive effect of the analgesic efficacy of hypnosis and VR distraction techniques. Other chronic ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocn.16928

Virtual reality used to distract children and young people ... VR has been suggested as an adjunct therapy to help manage pain in hospital patients and to treat conditions such as chronic headache in ...

5. thedermdigest.com thedermdigest.com/easing-pain-and-distress-in-dermatologic-procedures-a-review-of-virtual-reality-distraction-technologies/

Easing Pain and Distress in Dermatologic Procedures Virtual reality (VR) distraction has recently emerged as a cutting-edge and promising intervention for alleviating pain and distress during medical procedures.

6. journals.lww.com journals.lww.com/ajpd/fulltext/2024/02030/virtual_reality_for_procedural_distraction_for.3.aspx

Virtual Reality for Procedural Distraction for Children A pilot study was conducted to evaluate the usefulness of VR in reducing pain and anxiety in pediatric patients undergoing painful procedures. Fifty-five ...

7. eprints.bournemouth.ac.uk eprints.bournemouth.ac.uk/37524/3/VR%20to%20manage%20Eczema%20paper%20.pdf

Virtual Reality used to distract eczematous children from ... Virtual Reality used to distract eczematous children from distressing symptoms: a pilot evaluation. Dr Heidi Singleton, Lecturer in Children and Young ...