Actively Recruiting
Evaluating the Impact of Virtual Reality on Mood in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Essential Tremor
Led by Sunnybrook Health Sciences Centre · Updated on 2025-12-17
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how virtual reality (VR) videos affect anxiety levels before magnetic resonance-guided focused ultrasound (MRgFUS) treatment in adults with medication-resistant essential tremor. This randomized study compares two different 6-minute immersive VR videos to see how they influence pre-treatment anxiety and patient concerns like claustrophobia, mental readiness, and fear of pain. Participants will be randomly assigned to watch one of two VR videos using a Meta Quest 2 headset before their MRgFUS procedure. Both videos last six minutes and include sights and sounds that might impact mood. Standard preoperative care will be given to all participants, and the study will monitor how these VR experiences affect anxiety and related patient concerns. Participants will complete questionnaires measuring anxiety using the Visual Analogue Scale for Anxiety, Amsterdam Preoperative Anxiety and Information Scale, and State-Trait Anxiety Inventory at two times: two weeks before treatment and on the treatment day before the procedure. Feedback on the VR experience and any side effects will also be collected at these times. The study aims to better understand how VR can support patients undergoing MRgFUS for essential tremor, with participation lasting until after the treatment day assessments.
CONDITIONS
Brief Title
Evaluating the Impact of Virtual Reality on Mood in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Essential Tremor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be over the age of 18 and have been approved and consented for MRgFUS thalamotomy for medication-refractory essential tremor
- Subjects must be willing to give consent and able to attend all study visits and MRgFUS procedure, understanding the associated risks and benefits
- Participants must be willing or able to complete questionnaires or have someone who can complete them on their behalf
You will not qualify if you...
- Patients prone to epileptic seizures and/or sensory issues will be excluded
- Patients who have previously undergone an MRgFUS procedure (ipsilateral or contralateral to the hemisphere currently being treated) will be excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of MRgFUS procedure
Participants watch a 6-minute virtual reality (VR) video using a VR headset prior to undergoing the magnetic resonance-guided focused ultrasound (MRgFUS) procedure for essential tremor. This stage evaluates the impact of the VR video on preoperative anxiety and mood.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences
North York, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
L
Leila Harwood
N
Nadia Scantlebury, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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