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

NCT07287605 | Recruiting

• 1 other identifier: 6390
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preoperative Anxiety

Keywords

medication-refractory essential tremor; focused ultrasound; virtual reality intervention; MRgFUS; preoperative anxiety

Outcome Measures

Primary Outcomes (3)

• Evaluation of Anxiety Levels by Visual Analogue Scale for Anxiety (VAS-A)

  Participants will complete questionnaires to establish baseline anxiety levels. A 10-point numeric rating scale displayed horizontally, ranging from 0 = "Not at all anxious" to 10 = "Extremely anxious." Participants mark the number that best represents their current level of anxiety. Higher scores indicate greater anxiety.

  Questionnaires will be collected at two time points: 1.Baseline assessment day (two weeks before the MRgFUS procedure), before and after watching the VR video. 2.Treatment day, prior to the MRgFUS procedure.

• Evaluation of Anxiety Levels by Amsterdam Preoperative Anxiety and Information Scale (APAIS)

  Participants will complete questionnaires to establish baseline anxiety levels. The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a 12-item self-administered questionnaire used to assess preoperative anxiety. Each item is rated on a 5-point scale (1 = not at all to 5 = extremely). Higher scores indicate greater anxiety or information need. In this study, patient concerns may include anesthesia, head shaving, potential side effects and desire for additional procedural information.

  Questionnaires will be collected at two time points: 1.Baseline assessment day (two weeks before the MRgFUS procedure), before and after watching the VR video. 2.Treatment day, prior to the MRgFUS procedure.

• Evaluation of Anxiety Levels by State-Trait Anxiety Inventory - State Subscale (STAI-S)

  Participants will complete questionnaires to establish baseline anxiety levels. The State-Trait Anxiety Inventory - State Subscale (STAI-S) is a validated self-report questionnaire used to measure situational ("state") anxiety - how the participant feels "right now, at this moment." Each item is rated on a 4-point scale ranging from 1 = not at all to 4 = very much so. Higher scores indicating greater anxiety.

  Questionnaires will be collected at two time points: 1.Baseline assessment day (two weeks before the MRgFUS procedure), before and after watching the VR video. 2.Treatment day, prior to the MRgFUS procedure.

Secondary Outcomes (2)

• Participant feedback on the VR experience

  Feedback will be collected at two time points: 1.Baseline assessment day (two weeks before the MRgFUS procedure), before and after watching the VR video. 2.Treatment day, prior to the MRgFUS procedure.

• Adverse Effects Associated With Watching the VR Video

  Adverse effects will be monitored at two time points: 1.Baseline assessment day (two weeks before the MRgFUS procedure). 2.Treatment day, prior to the MRgFUS procedure.

Study Arms (2)

Exposure to Video number 1

EXPERIMENTAL

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.

Device: VR headset: video number 1

Exposure to Video number 2

EXPERIMENTAL

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.

Device: VR headset: video number 2

Interventions

VR headset: video number 2 DEVICE

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.

Exposure to Video number 2

VR headset: video number 1 DEVICE

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.

Exposure to Video number 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 and 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 may not qualify if:

• Patients prone to epileptic seizures and/or sensory issues will be excluded from the study.
• Patients who have previously undergone an MRgFUS procedure (ipsilateral or contralateral to the hemisphere currently being treated) will be excluded.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences

North York, Ontario, M4N 3M5, Canada

RECRUITING

Study Officials

• Dr. Jennifer Rabin, PhD, C.Psych

  Sunnybrook

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leila Harwood

CONTACT

4167796698; leila.harwood@sunnybrook.ca

Nadia Scantlebury, PhD

CONTACT

4164806100; leila.harwood@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to which of the two possible VR videos they will see.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Assigning participants to an intervention with VR exposure in order to assess the health outcomes of anxiety levels. Participants are blinded to which of the two possible VR videos they will see.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 17, 2025
• Study Start: June 19, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)