Comparing VR headset: video number 1 with VR headset: video number 2 for preoperative anxiety
Official title: Evaluating the Impact of Virtual Reality on Mood in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Essential Tremor
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.
Canadian Sites (1)
Sunnybrook Health Sciences
North York, Ontario, Canada
Eligibility Criteria
See who this study is looking for5 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: VR headset: video number 1, VR headset: video number 2.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 60 people.
The study is currently expected to finish around March 2027.
The main measurement is taken over: Questionnaires will be collected at two time points: 1.BaselineBaselineYour starting measurements, taken before treatment begins.Read more → assessment day (two weeks before the MRgFUS procedure), before and after watching the VR video. 2.Treatment day, prior to the MRgFUS procedure.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Evaluation of Anxiety Levels by Visual Analogue Scale for Anxiety (VAS-A) — measured over Questionnaires will be collected at two time points: 1.BaselineBaselineYour starting measurements, taken before treatment begins.Read more → 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) — measured over 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) — measured over 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.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07287605 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About VR headset: video number 1Device
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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About VR headset: video number 2Device
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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Questionnaires will be collected at two time points: 1.BaselineBaselineYour starting measurements, taken before treatment begins.Read more → assessment day (two weeks before the MRgFUS procedure), before and after watching the VR video. 2.Treatment day, prior to the MRgFUS procedure..
The study as a whole is currently expected to finish around 2027-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 60 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: North York, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.