Recruiting

VR Glasses

Sponsor:

Boston University

Code:

NCT06723158

Conditions

Procedural Anxiety

Procedural Pain

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Not accepted

Interventions

Virtual reality (VR) glasses with relaxation module

Study Details

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. 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

Study ID

NCT06723158

Start date

Nov 18, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Virtual reality (VR) glasses with relaxation module

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

Primary outcome measure

  • Level of anxiety [ Time Frame: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery ]
  • Level of depression [ Time Frame: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery ]
  • Amount of Midazolam used [ Time Frame: pre-incision, 30 minutes post incision, 60 minutes post incision ]
  • Amount of Fentanyl used [ Time Frame: pre-incision, 30 minutes post incision, 60 minutes post incision ]
  • Amount of Propofol used [ Time Frame: pre-incision, 30 minutes post incision, 60 minutes post incision ]
  • Amount of Ketamine used [ Time Frame: pre-incision, 30 minutes post incision, 60 minutes post incision ]

Central Contacts and Locations

Central contacts

Radhika Chigurupati, DMD MS

617-638-4386rchiguru@bu.edu

Paul Wiley, MS

617-638-4386pjwile20@bu.edu

Locations

Goldman School of Dental Medicine, Oral and Maxillofacial Surgery Clinic

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Radhika Chigurupati, DMD MS

617-638-4386rchiguru@bu.edu

More Information

Sponsor

Boston University

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University on 2026-07-27.