Oral Surgery Virtual Reality Glasses Study
Purpose
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).
Conditions
- Procedural Anxiety
- Procedural Pain
Eligibility
- Eligible Ages
- Between 16 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized group allocation (1:1 block size of 2 for randomization)
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Virtual Reality (VR) Intervention Group |
Participants randomized to this group will receive VR glasses with a relaxation module (audio, visual) to wear during IV placement, induction of anesthesia, and during the procedure. |
|
|
No Intervention Virtual Reality (VR) Control Group |
Participants randomized to this group will receive VR glasses without a relaxation module to be worn only as safety glasses, during IV placement, induction of anesthesia, and during the procedure. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Boston University
