Procedural Anxiety, Procedural Pain
Conditions
Keywords
Virtual reality glasses, Non emergent oral surgery, IV sedation, Patient Health Questionnaire (PHQ), Generalized Anxiety Disorder (GAD)
Brief 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. 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
OTHERVirtual reality (VR) glasses with relaxation module
The relaxation module will include immersive video and audio components as a distraction from the medical procedures.
Sponsors
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized group allocation (1:1 block size of 2 for randomization)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of anxiety | 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery | 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. |
| Level of depression | 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery | 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. |
| Amount of Midazolam used | pre-incision, 30 minutes post incision, 60 minutes post incision | The amount of this drug used will be abstracted form the medical record of each participant. |
| Amount of Fentanyl used | pre-incision, 30 minutes post incision, 60 minutes post incision | The amount of this drug used will be abstracted form the medical record of each participant. |
| Amount of Propofol used | pre-incision, 30 minutes post incision, 60 minutes post incision | The amount of this drug used will be abstracted form the medical record of each participant. |
| Amount of Ketamine used | pre-incision, 30 minutes post incision, 60 minutes post incision | The amount of this drug used will be abstracted form the medical record of each participant. |
Countries
United States
Contacts
CONTACTRadhika Chigurupati, DMD MS
CONTACTPaul Wiley, MS
PRINCIPAL_INVESTIGATORRadhika Chigurupati, DMD MS
Goldman School of Dental Medicine, Oral and Maxillofacial Surgery
Outcome results
None listed