Clinical trial NCT06723158: Oral Surgery Virtual Reality Glasses Study
Official title: Investigating the Impact of Virtual Reality Glasses on Sedation Requirement and Patient Experience in Patients Undergoing Oral Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Procedural Anxiety
Procedural Pain
Keywords: Virtual reality glasses
Non emergent oral surgery
IV sedation
Patient Health Questionnaire (PHQ)
Generalized Anxiety Disorder (GAD)
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized group allocation (1:1 block size of 2 for randomization)
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Level of anxiety
timeFrame: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery
measure: Level of depression
timeFrame: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery
measure: Amount of Midazolam used
timeFrame: pre-incision, 30 minutes post incision, 60 minutes post incision
measure: Amount of Fentanyl used
timeFrame: pre-incision, 30 minutes post incision, 60 minutes post incision
measure: Amount of Propofol used
timeFrame: pre-incision, 30 minutes post incision, 60 minutes post incision
measure: Amount of Ketamine used
timeFrame: pre-incision, 30 minutes post incision, 60 minutes post incision
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Goldman School of Dental Medicine, Oral and Maxillofacial Surgery Clinic
state: Massachusetts
Study officials:
affiliation: Goldman School of Dental Medicine, Oral and Maxillofacial Surgery
name: Radhika Chigurupati, DMD MS
role: PRINCIPAL_INVESTIGATOR
References: