Preoperative AnxietyNCT07287605
Evaluating the Impact of Virtual Reality on Mood in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Essential Tremor
A study testing VR headset: video number 1 and VR headset: video number 2 in people with Preoperative Anxiety, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- VR headset: video number 1 and VR headset: video number 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jun 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences
North York, Ontario, M4N 3M5
Leila Harwood, 416-779-6698, leila.harwood@sunnybrook.ca
Dr. Jennifer Rabin, PhD, C.Psych
About this study
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.
Read the 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
- Being tested
- VR headset: video number 1, VR headset: video number 2
- Keywords
- medication-refractory essential tremor, focused ultrasound, virtual reality intervention, MRgFUS, preoperative anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: VR headset: video number 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Participants will be asked to provide feedback on the VR experience.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start19 Jun 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Jennifer Rabin, PhD, C.Psych, Principal investigator, Sunnybrook
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287605
- Sponsor's protocol ID
- 6390
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Virtual Reality on Mood in Patients Undergoing Magnetic Resonance-Guided Focused Ultrasound for Medication-Refractory Essential Tremor
- ClinicalTrials.gov ID
- NCT07287605
- Acronym / sponsor ID
- 6390
- Conditions
- Preoperative Anxiety
- Keywords
- medication-refractory essential tremor, focused ultrasound, virtual reality intervention, MRgFUS, preoperative anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exposure to Video number 1 | Experimental | Device: VR headset: video number 1Each 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. |
| Exposure to Video number 2 | Experimental | Device: VR headset: video number 2Each 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR headset: video number 1A 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 | Exposure to Video number 1 |
| VR headset: video number 2A 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 | Exposure to Video number 2 |
Primary outcome
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.
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)
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.
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)
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.
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.
2 secondary outcomes
Participant feedback on the VR experience
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Jennifer Rabin, PhD, C.Psych principal investigator
Sunnybrook
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR headset: video number 1 and VR headset: video number 2 in people with Preoperative Anxiety, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leila Harwood (4167796698, leila.harwood@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.