Relaxing virtual reality glasses during non-emergency oral surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.