Anxiety & Depression Association of America

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.	Other: Virtual reality (VR) glasses with relaxation module The relaxation module will include immersive video and audio components as a distraction from the medical procedures.
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

Study Contact

Radhika Chigurupati, DMD MS
617-638-4386
rchiguru@bu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.