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Recruiting NCT06723158

Oral Surgery Virtual Reality Glasses Study

No phase Interventional Procedural Anxiety Procedural Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual reality (VR) glasses with relaxation module.
Who it may be relevant to
Registry conditions: Procedural Anxiety, Procedural Pain. Basic parameters: 16 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Goldman School of Dental Medicine, Oral and Maxillofacial Surgery Clinic — Boston

Identifiers

NCT: NCT06723158 · H-45038

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗