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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Virtual reality (VR) glasses with relaxation module
Other interventionThe relaxation module will include immersive video and audio components as a distraction from the medical procedures.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality (VR) Intervention GroupExperimental treatment 1 intervention
Group B: Virtual Reality (VR) Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery2
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.
Time frame
3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery3
Amount of Midazolam used
The amount of this drug used will be abstracted form the medical record of each participant.
Time frame
pre-incision, 30 minutes post incision, 60 minutes post incision4
Amount of Fentanyl used
The amount of this drug used will be abstracted form the medical record of each participant.
Time frame
pre-incision, 30 minutes post incision, 60 minutes post incisionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov