Relaxing virtual reality glasses during non-emergency oral surgery
Investigating the Impact of Virtual Reality Glasses on Sedation Requirement and Patient Experience in Patients Undergoing Oral Surgery
This trial will test whether wearing relaxing virtual reality (VR) glasses during non-emergency oral surgery with IV sedation helps patients feel more comfortable and need less sedative medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Boston University Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06723158 on ClinicalTrials.gov |
What this trial studies
Eighty patients requiring non-emergent oral surgery under IV sedation will be randomized 1:1 to wear VR glasses that play a relaxing audio-visual module or to wear VR glasses that function only as eye protection. The study’s co-primary goals are to see if VR improves patient tolerance during IV access, sedation induction, and the surgical procedure, and whether it reduces the total sedation required. Eligible participants are ASA class I or II and must be able to use and tolerate VR; people with seizure history, significant sensory or cognitive impairment, pregnancy, or motion sickness intolerance are excluded. The single-center trial is conducted at Boston University’s Goldman School of Dental Medicine and compares patient experience and sedative dosing between the two groups.
Who should consider this trial
Good fit: People who need non-emergency oral surgery with IV sedation, are ASA I or II, can give informed consent (or have a guardian for minors), and can tolerate VR are ideal candidates.
Not a fit: Patients with seizure disorders, significant uncorrected vision or hearing loss, severe motion sickness, cognitive impairment, pregnancy, or those who do not require IV sedation are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, using relaxing VR could make oral surgery under IV sedation more comfortable for patients and reduce the amount of sedative medication needed.
How similar studies have performed: Comparable VR distraction approaches have shown modest reductions in procedural anxiety and pain in other clinical settings, but evidence specifically targeting IV-sedated oral surgery is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Goldman School of Dental Medicine, Oral and Maxillofacial Surgery Clinic — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Radhika Chigurupati, DMD MS — Goldman School of Dental Medicine, Oral and Maxillofacial Surgery
- Study coordinator: Radhika Chigurupati, DMD MS
- Email: rchiguru@bu.edu
- Phone: 617-638-4386
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.