Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-11-18
2026-03-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Virtual Reality (VR) Intervention Group
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.
Virtual reality (VR) glasses with relaxation module
The relaxation module will include immersive video and audio components as a distraction from the medical procedures.
Virtual Reality (VR) Control Group
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.
No interventions assigned to this group
Interventions
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Virtual reality (VR) glasses with relaxation module
The relaxation module will include immersive video and audio components as a distraction from the medical procedures.
Eligibility Criteria
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Inclusion Criteria
* 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 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
16 Years
65 Years
ALL
No
Sponsors
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Boston University
OTHER
Responsible Party
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Principal Investigators
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Radhika Chigurupati, DMD MS
Role: PRINCIPAL_INVESTIGATOR
Goldman School of Dental Medicine, Oral and Maxillofacial Surgery
Locations
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Goldman School of Dental Medicine, Oral and Maxillofacial Surgery Clinic
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-45038
Identifier Type: -
Identifier Source: org_study_id
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