Oral Surgery Virtual Reality Glasses Study

Investigating the Impact of Virtual Reality Glasses on Sedation Requirement and Patient Experience in Patients Undergoing Oral Surgery

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).

Study Overview

• Status: Recruiting
• Conditions: Procedural Pain; Procedural Anxiety
• Intervention / Treatment: Other: Virtual reality (VR) glasses with relaxation module

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Radhika Chigurupati, DMD MS; Phone Number: 617-638-4386; Email: rchiguru@bu.edu
• Study Contact Backup: Name: Paul Wiley, MS; Phone Number: 617-638-4386; Email: pjwile20@bu.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Goldman School of Dental Medicine, Oral and Maxillofacial Surgery Clinic
      • Contact: Radhika Chigurupati, DMD MS; Phone Number: 617-638-4386; Email: rchiguru@bu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of anxiety	Scores from the General Anxiety Disorder-7 (GAD-7) will be used to assess the level of anxiety. It is a 7-item instrument with each item scored from 0=Not at all to 3=Nearly every day. GAD-7 total scores for the can range from 0 to 21 with higher scores suggesting more anxiety. The scores are interpreted as 0-4: minimal anxiety, 5-9: mild anxiety, 10-14: moderate anxiety, and 15-21: severe anxiety.	3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery
Amount of Fentanyl used	The amount of this drug used will be abstracted form the medical record of each participant.	pre-incision, 30 minutes post incision, 60 minutes post incision
Amount of Propofol used	The amount of this drug used will be abstracted form the medical record of each participant.	pre-incision, 30 minutes post incision, 60 minutes post incision
Amount of Ketamine used	The amount of this drug used will be abstracted form the medical record of each participant.	pre-incision, 30 minutes post incision, 60 minutes post incision
Level of depression	Scores from the Patient Health Questionnaire (PHQ-9) will be used to assess the level of depression. It is a 9-item depression screening tool with each item scored from 0=Not at all to 3=Nearly every day. Scores can range from 0 to 27, with higher scores suggesting more depression. The scores are interpreted as 0-4: None or minimal depression, 5-9: Mild depression, 10-14: Moderate depression, 15-19: Moderately severe depression, and 20-27: Severe depression.	3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery
Amount of Midazolam used	The amount of this drug used will be abstracted form the medical record of each participant.	pre-incision, 30 minutes post incision, 60 minutes post incision

Collaborators and Investigators

• Sponsor: Boston University
• Investigators: Principal Investigator: Radhika Chigurupati, DMD MS, Goldman School of Dental Medicine, Oral and Maxillofacial Surgery

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Actual): December 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Virtual reality glasses; Generalized Anxiety Disorder (GAD); IV sedation; Non emergent oral surgery; Patient Health Questionnaire (PHQ)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Anxiety Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural; Generalized Anxiety Disorder; Equipment and Supplies; Optical Devices; Lenses; Eyeglasses
• Other Study ID Numbers: H-45038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No