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.
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.
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.
Parallel
VR headset: video number 1
DeviceA 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
DeviceA 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.
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.
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.
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.
Participant feedback on the VR experience
Participants will be asked to provide feedback on the VR experience.
Adverse Effects Associated With Watching the VR Video
Participants will be monitored for any adverse effects experienced during or immediately after viewing the VR video. Reported effects may include, but are not limited to, dizziness, nausea, eye strain, headache, motion sickness, or discomfort related to wearing the VR headset. All adverse effects will be self-reported by participants. The frequency, type, and severity of adverse effects will be recorded and compared between the two randomized VR video groups.
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