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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
The relaxation module will include immersive video and audio components as a distraction from the medical procedures.
Goldman School of Dental Medicine, Oral and Maxillofacial Surgery Clinic
Boston, Massachusetts, United States
RECRUITINGLevel 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 surgery
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 surgery
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 incision
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 incision
Amount of Propofol 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 incision
Amount of Ketamine 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 incision
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