Oral Surgery Virtual Reality Glasses Study

Boston University

Status: Enrolling

Conditions: Procedural Anxiety; Procedural Pain

Treatments: Other: Virtual reality (VR) glasses with relaxation module

Study type: Interventional

Funder types: Other

Identifiers

NCT06723158

H-45038

Details and patient eligibility

About

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).

Enrollment: 80 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Virtual Reality (VR) Intervention Group

Experimental group

Description:

Participants randomized to this group will receive VR glasses with a relaxation module (audio, visual) to wear during IV placement, induction of anesthesia, and during the procedure.

Treatment:

Other: Virtual reality (VR) glasses with relaxation module

Virtual Reality (VR) Control Group

No Intervention group

Description:

Participants randomized to this group will receive VR glasses without a relaxation module to be worn only as safety glasses, during IV placement, induction of anesthesia, and during the procedure.