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This arm will be the current standard of care

This arm will use the vibroacoustic device to provide a mechanical stimulus to the patient as treatment to reduce pain and anxiety. Augmented reality glasses will be worn but will be turned off.

This arm will use the augmented reality game to provide a visual stimulus to the patient as treatment to reduce pain and anxiety. Vibroacoustic device will be worn but will be turned off.

This arm will use both the augmented reality game and vibroacoustic device to provide a visual stimulus to the patient as treatment to reduce pain and anxiety.

Mechanical stimulus is provided to the patient through a vibroacoustic device via vibration around the neck.

Vibroacoustic stimulation on

Visual stimulus is provided through augmented reality glasses in the form of a game.

Augmented Reality on

Vibroacoustic device is worn but turned off.

Vibroacoustic stimulation off

Augmented reality glasses are worn but turned off.

Augmented reality off

James J Daniero, MD

Elena Miller, MPH

James Daniero, MD

Claudia N Gutierrez, MD

Adithya Reddy, BSE

In-office procedures (IOPs) are a cost-effective, and safe alternative to many operating room procedure, with benefits such as reduced anesthesia risk. One of the major causes of failed in-office procedures or requirement of conversion to the operating room is poor patient tolerance. Vibration and augmented reality (AR) can be used as non-pharmacologic treatment options to treat patient anxiety and pain by using the physiology proposed by the gate-way theory of pain as well as distraction. This study seeks to compare anxiety and pain perception with patient reported survey data, as well as physiologic indicators of stress such as heart rate variability (HRV) within patients undergoing IOPs in a laryngology office with and without vibration and AR treatment.

In-office procedures (IOPs) represent a cost-effective and safe alternative to operating room procedures for a myriad of disease processes across medical and surgical specialties. IOPs are performed under local anesthetic without general anesthesia or sedation, resulting in faster and often safer procedures by eliminating risks associated with general anesthesia. IOPs are primarily limited by patient tolerance, as there is a lack of currently available non-pharmacologic treatment options for patient anxiety, stress, discomfort, and pain during these procedures.

The Gate Control Theory of Pain postulates that only a limited amount of simultaneous sensory stimuli can be processed by the central nervous system and therefore non-painful stimuli, such as vibration or virtual distraction (i.e. virtual or augmented reality), can eliminate or lessen the perception of concurrent painful stimuli. The use of these non-painful stimuli has been shown to have clinical utility in the setting of procedures such as percutaneous injections and wound dressing changes.

However, the coupling of multiple sensory distraction techniques has not been described for IOPs. Furthermore, no investigation of sensory distraction techniques to reduce patient discomfort within the field of otolaryngology has been conducted. The focus of the proposed project is to improve patient experience during IOPs by coupling a novel vibroacoustic stimulation device with original AR software applications.

In-office otolaryngology procedures specifically involve using a rigid endoscope or a flexible nasolarynogoscopy to visualize the inside of a patient nose, sinus, posterior oropharynx, and vocal cords. Using these imaging modalities, awake, in-office procedures can be performed. However, these procedures are often very uncomfortable and anxiety producing.

The goal of the study is to determine whether or not wearing an augmented reality headset with a novel game and vibroacoustic simulation device can help reduce anxiety and improve the patient experience of in-office otolaryngology procedures. The device consists of an augmented reality headset worn by the patient, a vibration device that is applied to the patient's neck to help reduce the sensation of the procedure, and a clicker that allows the patient to interact with the augmented reality game environment.

Patients who are undergoing in-office laryngology procedures (procedures on their vocal cords) will be randomized into a control group augmented reality (AR) group, vibration group, and combined AR and vibration group. The control group will wear a sham augmented reality head set during the procedure. The AR group will have a game played on the head set to distract them during the procedure. The patient will interact with the game use a hand held clicker.

Each participant will answer a survey before and after the procedure assessing their anxiety. Each participant will also wear a one-lead EKG to measure their heart rate through the procedure. The subjective and physiological level will be compared between the two groups

Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures

Using Augmented Reality With Vibroacoustic Stimulation to Improve the Patient Experience During In-Office Otorhinolaryngology Procedures

There is no intention to share individual participant data with other researchers.

Visual analog scale rating of max perceived pain during procedure

Visual analog scale rating of average perceived pain during procedure

Visual analog scale rating of how nervous about pain patient was during procedure

Visual analog scale rating of percent of time spent thinking about pain during procedure

Difference between heart rate variability during procedure compared with pre-procedure

Difference between maximum heart rate during procedure compared with pre-procedure

Difference between average heart rate during procedure compared with pre-procedure

Measure change in Stait-Trait anxiety inventory State 5 question score pre and post-procedure.

Likert scale rating of satisfaction of treatment group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures	NCT06227039	Pain, Acute Vocal Fold Poly... Vocal Cord Para... Laryngeal Neopl...	Vibroacoustic s... Augmented Reali... Vibroacoustic s... Augmented reali...	18 Years -	University of Virginia
Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures	NCT06227039	Pain, Acute Vocal Fold Poly... Vocal Cord Para... Laryngeal Neopl...	Vibroacoustic s... Augmented Reali... Vibroacoustic s... Augmented reali...	18 Years -	University of Virginia

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