Oral Surgery Virtual Reality Glasses Study (NCT06723158) | Clinical Trial Compass
RecruitingNot Applicable
Oral Surgery Virtual Reality Glasses Study
United States80 participantsStarted 2025-11-18
Plain-language summary
The goal of this randomized trial is to investigate if using virtual reality (VR) glasses for patients who require non-emergent oral surgery procedures under intravenous (IV) sedation improves their overall experience compared to using standard of care safety glasses.
This study has two primary objectives.
1. To evaluate if VR glasses can improve patient tolerance during IV access, sedation induction, and the surgical procedure.
2. To investigate whether the use of VR glasses reduces the amount of sedation required for induction and throughout the oral surgery procedure.
80 subjects will be randomly assigned 1:1 to either wear VR glasses playing a relaxing video and audio or VR glasses that will only serve as eye protection (control group).
Who can participate
Age range
16 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients requiring IV sedation for oral surgery procedure
* Patients able to understand the use of virtual reality glasses and provide informed consent/assent
* Patients classified as American Society of Anesthesiologists (ASA) I or II
* No reported substance use within the previous 24 hours
* No reported excessive alcohol consumption
* Willingness to wear eye protection
* Willingness to use certified interpreters if required
* A legal guardian must accompany minors
Exclusion Criteria:
* Patient with hearing aids or severe hearing impairment
* Patient with blindness or significant visual impairment that is not corrected by contact lenses
* Patients with cognitive impairments determined and assessed by the researchers
* Pregnant women or women who could be pregnant based on self reporting
* Patients unable to tolerate virtual reality glasses due to motion sickness or other issues
* Patients with history of seizures or epilepsy per self report
* Patients who cannot tolerate VR glasses due to discomfort or a medical emergency that arises during the procedure
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Level of anxiety
Timeframe: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery
2
Level of depression
Timeframe: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery
3
Amount of Midazolam used
Timeframe: pre-incision, 30 minutes post incision, 60 minutes post incision
4
Amount of Fentanyl used
Timeframe: pre-incision, 30 minutes post incision, 60 minutes post incision
5
Amount of Propofol used
Timeframe: pre-incision, 30 minutes post incision, 60 minutes post incision
6
Amount of Ketamine used
Timeframe: pre-incision, 30 minutes post incision, 60 minutes post incision