Oral Surgery Virtual Reality Glasses Study

NCT06723158 | Recruiting

• 1 other identifier: H-45038
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 1.To evaluate if VR glasses can improve patient tolerance during IV access, sedation induction, and the surgical procedure.
2. 2.To investigate whether the use of VR glasses reduces the amount of sedation required for induction and throughout the oral surgery procedure.

Conditions

Procedural Anxiety; Procedural Pain

Keywords

Virtual reality glasses; Non emergent oral surgery; IV sedation; Patient Health Questionnaire (PHQ); Generalized Anxiety Disorder (GAD)

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

Study Arms (2)

Virtual Reality (VR) Intervention Group

EXPERIMENTAL

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

Virtual Reality (VR) Control Group

NO INTERVENTION

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.

Interventions

Virtual reality (VR) glasses with relaxation module OTHER

The relaxation module will include immersive video and audio components as a distraction from the medical procedures.

Virtual Reality (VR) Intervention Group

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Goldman School of Dental Medicine, Oral and Maxillofacial Surgery Clinic

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Pain, Procedural; Generalized Anxiety Disorder

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Radhika Chigurupati, DMD MS

  Goldman School of Dental Medicine, Oral and Maxillofacial Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radhika Chigurupati, DMD MS

CONTACT

617-638-4386; rchiguru@bu.edu

Paul Wiley, MS

CONTACT

617-638-4386; pjwile20@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized group allocation (1:1 block size of 2 for randomization)

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: November 18, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)