Virtual Reality for Anxiety

Overseen By Nadia Scantlebury, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

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

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective of this randomized study is to evaluate the effect of a virtual reality (VR) video on pre-treatment anxiety levels in individuals undergoing magnetic resonance-guided focused ultrasound (MRgFUS) treatment for medication-refractory essential tremor (ET). Participants will be randomized to view one of two VR videos, and pre-treatment anxiety levels will be compared between groups.

As a secondary objective, the study will compare patient concerns (including claustrophobia, mental preparedness, and fear of pain, as well as any additional concerns identified during the study) between the two randomized groups.

Who Is on the Research Team?

Dr. Jennifer Rabin, PhD, C.Psych

Principal Investigator

Sunnybrook

Are You a Good Fit for This Trial?

This trial is for individuals with essential tremor that doesn't respond to medication and are about to undergo MRgFUS treatment. Participants should be experiencing anxiety related to their condition or the upcoming procedure.

Inclusion Criteria

Subjects must be willing to give consent and able to attend all study visits and MRgFUS procedure, understanding the associated risks and benefits

I am over 18 and have agreed to a specific procedure for my severe tremor.

I can complete questionnaires or have someone who can do it for me.

Exclusion Criteria

Patients prone to epileptic seizures and/or sensory issues

I have had a focused ultrasound surgery on my brain before.

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview

The study tests whether watching one of two different VR videos before treatment can reduce pre-treatment anxiety in patients. It's a randomized study, meaning participants will be randomly assigned to watch one of the two videos.

How Is the Trial Designed?

Group I: Exposure to Video number 2 Experimental Treatment 1 Intervention

Each participant will be randomized to watch Video number 2, 6-minute VR video associated with the study. Participants will be blinded to the type of video. The study will evaluate the impact of the sights and sounds in the video on anxiety levels.

Group II: Exposure to Video number 1 Experimental Treatment 1 Intervention

Each participant will be randomized to watch Video number 1, 6-minute VR video associated with the study. Participants will be blinded to the type of video. The study will evaluate the impact of the sights and sounds in the video on anxiety levels.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+