Oral Surgery Virtual Reality Glasses Study

Phase

N/A

Condition

Panic Disorders

Anxiety Disorders

Treatment

Virtual reality (VR) glasses with relaxation module

Clinical Study ID

NCT06723158

H-45038

Ages 16-65
All Genders

Study 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.

To evaluate if VR glasses can improve patient tolerance during IV access, sedation induction, and the surgical procedure.
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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients requiring IV sedation for oral surgery procedure
Patients able to understand the use of virtual reality glasses and provide informedconsent/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

Exclusion Criteria:

Patient with hearing aids or severe hearing impairment
Patient with blindness or significant visual impairment that is not corrected bycontact 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 otherissues
Patients with history of seizures or epilepsy per self report
Patients who cannot tolerate VR glasses due to discomfort or a medical emergencythat arises during the procedure

Study Design