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NCT Number: NCT06723158

Oral Surgery Virtual Reality Glasses Study

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).

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Key information

Conditions

Procedural Anxiety Anxiety Disorders Generalized Anxiety Disorder Mental Disorders Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Procedural Pain Signs and Symptoms

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goldman School of Dental Medicine, Oral and Maxillofacial Surgery Clinic

Boston, Massachusetts, 02118, United States

Location status: Recruiting

Location contact

Radhika Chigurupati, DMD MS

CONTACT

[email protected]

617-638-4386

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality (VR) glasses with relaxation module

Other

The relaxation module will include immersive video and audio components as a distraction from the medical procedures.

Primary outcomes

  1. Level of anxiety

    Time frame: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery

    Scores from the General Anxiety Disorder-7 (GAD-7) will be used to assess the level of anxiety. It is a 7-item instrument with each item scored from 0=Not at all to 3=Nearly every day. GAD-7 total scores for the can range from 0 to 21 with higher scores suggesting more anxiety. The scores are interpreted as 0-4: minimal anxiety, 5-9: mild anxiety, 10-14: moderate anxiety, and 15-21: severe anxiety.

  2. Level of depression

    Time frame: 3 days before oral surgery, immediately before surgery, immediately after surgery, about 8 hours after surgery

    Scores from the Patient Health Questionnaire (PHQ-9) will be used to assess the level of depression. It is a 9-item depression screening tool with each item scored from 0=Not at all to 3=Nearly every day. Scores can range from 0 to 27, with higher scores suggesting more depression. The scores are interpreted as 0-4: None or minimal depression, 5-9: Mild depression, 10-14: Moderate depression, 15-19: Moderately severe depression, and 20-27: Severe depression.

  3. Amount of Midazolam used

    Time frame: pre-incision, 30 minutes post incision, 60 minutes post incision

    The amount of this drug used will be abstracted form the medical record of each participant.

  4. Amount of Fentanyl used

    Time frame: pre-incision, 30 minutes post incision, 60 minutes post incision

    The amount of this drug used will be abstracted form the medical record of each participant.

  5. Amount of Propofol used

    Time frame: pre-incision, 30 minutes post incision, 60 minutes post incision

    The amount of this drug used will be abstracted form the medical record of each participant.

  6. Amount of Ketamine used

    Time frame: pre-incision, 30 minutes post incision, 60 minutes post incision

    The amount of this drug used will be abstracted form the medical record of each participant.

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Wiley, MS

CONTACT

[email protected]

617-638-4386

Radhika Chigurupati, DMD MS

CONTACT

[email protected]

617-638-4386

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Official study title

Investigating the Impact of Virtual Reality Glasses on Sedation Requirement and Patient Experience in Patients Undergoing Oral Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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