Recruiting

VR & MRgFUS

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT07287605

Conditions

Preoperative Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VR headset: video number 1

VR headset: video number 2

Study Details

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

Study ID

NCT07287605

Start date

Jun 19, 2025

Status verified date

Nov, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exposure to Video number 1

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.

experimental: Exposure to Video number 2

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.

Interventions

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.

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.

Primary outcome measure

  • Evaluation of Anxiety Levels by Visual Analogue Scale for Anxiety (VAS-A) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Leila Harwood

4167796698leila.harwood@sunnybrook.ca

Nadia Scantlebury, PhD

4164806100leila.harwood@sunnybrook.ca

Locations

Sunnybrook Health Sciences

Recruiting

North York, Ontario, Canada, M4N 3M5

Contacts

Leila Harwood

416-779-6698leila.harwood@sunnybrook.ca

Principal Investigator:

Dr. Jennifer Rabin, PhD, C.Psych

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Dec 17, 2025

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2025-12-17.