NCT07287605

Evaluating the Impact of Virtual Reality on Mood in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Essential Tremor

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study will evaluate the effectiveness of a virtual reality (VR) intervention in reducing preoperative anxiety among adults scheduled to undergo magnetic resonance-guided focused ultrasound (MRgFUS) for essential tremor. Sixty adult participants scheduled for MRgFUS will be randomized to view one of two 6-minute immersive VR procedural videos using a headset prior to treatment. Preoperative anxiety will be assessed using validated self-report instruments, including the Visual Analogue Scale for Anxiety (VAS), the Amsterdam Preoperative Anxiety and Information Scale (APAIS), and the State-Trait Anxiety Inventory - State version (STAI-S). The primary objective is to compare preoperative anxiety levels between the two VR video groups. A secondary objective is to compare patient concerns between groups, including but not limited to claustrophobia, mental preparedness, and fear of pain, as well as any additional concerns identified through patient reporting.

Conditions

• Preoperative Anxiety

Interventions

Type	Name	Description
DEVICE	VR headset: video number 1	A 6-minute virtual reality (VR) video that contains sights and sounds that might affect mood. The video is viewed on a Meta Quest 2 (128GB) VR headset with Touch Controllers. Standard preoperative care is provided to all participants.
DEVICE	VR headset: video number 2	A 6-minute virtual reality (VR) video that contains sights and sounds that might affect mood. The video is viewed on a Meta Quest 2 (128GB) VR headset with Touch Controllers. Standard preoperative care is provided to all participants.

Timeline

• Start date: 2025-06-19
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: Canada