Oral Surgery Virtual Reality Glasses Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-65
SponsorBoston University
About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Virtual reality (VR) glasses with relaxation module
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov