Oral Surgery Virtual Reality Glasses Study
Recruiting · NCT06723158 · Interventional (participants receive a specific treatment) · Lead sponsor: Boston University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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
Where it is running
1 location listed across 1 US state.
- Goldman School of Dental Medicine, Oral and Maxillofacial Surgery Clinic - Boston, Massachusetts, United States