Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures

Pain, Acute Clinical Trial

— PARVA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06227039
• Other study ID #: HSR210111
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of Virginia
• Contact: James J Daniero, MD
• Phone: 4349242040
• Email: jjd5h[@]uvahealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing office-based laryngology procedure performed at home institution.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Acute Pain
• Laryngeal Neoplasms
• Pain, Acute
• Paralysis
• Vocal Cord Paralysis
• Vocal Fold Polyp

Intervention

Other:
• Vibroacoustic stimulation on
Mechanical stimulus is provided to the patient through a vibroacoustic device via vibration around the neck.
• Augmented Reality on
Visual stimulus is provided through augmented reality glasses in the form of a game.
• Vibroacoustic stimulation off
Vibroacoustic device is worn but turned off.
• Augmented reality off
Augmented reality glasses are worn but turned off.

Locations

Country	Name	City	State
United States	UVA Fontaine Research Park Building 415	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (13)

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Hoffer EP. The American Health Care System Is Broken. Part 7: How Can We Fix It? Am J Med. 2019 Dec;132(12):1381-1385. doi: 10.1016/j.amjmed.2019.10.003. Epub 2019 Oct 24. — View Citation

Legrain V, Damme SV, Eccleston C, Davis KD, Seminowicz DA, Crombez G. A neurocognitive model of attention to pain: behavioral and neuroimaging evidence. Pain. 2009 Aug;144(3):230-232. doi: 10.1016/j.pain.2009.03.020. Epub 2009 Apr 18. No abstract available. — View Citation

Mally P, Czyz CN, Chan NJ, Wulc AE. Vibration anesthesia for the reduction of pain with facial dermal filler injections. Aesthetic Plast Surg. 2014 Apr;38(2):413-8. doi: 10.1007/s00266-013-0264-4. Epub 2014 Jan 24. — View Citation

McCarthy M. US health-care system faces cost and insurance crises. Rising costs, growing numbers of uninsured, and quality gaps trouble world's most expensive health-care system. Lancet. 2003 Aug 2;362(9381):375. doi: 10.1016/s0140-6736(03)14057-3. No abstract available. — View Citation

Rice T, Rosenau P, Unruh LY, Barnes AJ, Saltman RB, van Ginneken E. United States of America: health system review. Health Syst Transit. 2013;15(3):1-431. — View Citation

Saini AT, Citardi MJ, Yao WC, Luong AU. Office-Based Sinus Surgery. Otolaryngol Clin North Am. 2019 Jun;52(3):473-483. doi: 10.1016/j.otc.2019.02.003. Epub 2019 Mar 22. — View Citation

Shah PD. Patient Safety and Quality for Office-Based Procedures in Otolaryngology. Otolaryngol Clin North Am. 2019 Feb;52(1):89-102. doi: 10.1016/j.otc.2018.08.015. Epub 2018 Sep 22. — View Citation

Sharma P, Czyz CN, Wulc AE. Investigating the efficacy of vibration anesthesia to reduce pain from cosmetic botulinum toxin injections. Aesthet Surg J. 2011 Nov;31(8):966-71. doi: 10.1177/1090820X11422809. Epub 2011 Oct 14. — View Citation

Smith KC, Comite SL, Balasubramanian S, Carver A, Liu JF. Vibration anesthesia: a noninvasive method of reducing discomfort prior to dermatologic procedures. Dermatol Online J. 2004 Oct 15;10(2):1. — View Citation

Treede RD. Gain control mechanisms in the nociceptive system. Pain. 2016 Jun;157(6):1199-1204. doi: 10.1097/j.pain.0000000000000499. — View Citation

Young S, Shapiro FE, Urman RD. Office-based surgery and patient outcomes. Curr Opin Anaesthesiol. 2018 Dec;31(6):707-712. doi: 10.1097/ACO.0000000000000655. — View Citation

Zhang Y, Liu S, Zhang YQ, Goulding M, Wang YQ, Ma Q. Timing Mechanisms Underlying Gate Control by Feedforward Inhibition. Neuron. 2018 Sep 5;99(5):941-955.e4. doi: 10.1016/j.neuron.2018.07.026. Epub 2018 Aug 16. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Max pain experienced	Visual analog scale rating of max perceived pain during procedure	measured post-treatment (1 hr).
Primary	Average pain experienced	Visual analog scale rating of average perceived pain during procedure	measured post-treatment (1 hr).
Primary	Pain nervousness experienced	Visual analog scale rating of how nervous about pain patient was during procedure	measured post-treatment (1 hr).
Primary	Time spent thinking about pain	Visual analog scale rating of percent of time spent thinking about pain during procedure	measured post-treatment (1 hr).
Primary	Change in heart rate variability during procedure	Difference between heart rate variability during procedure compared with pre-procedure	calculated post-treatment (1 hr).
Primary	Change in maximum heart rate	Difference between maximum heart rate during procedure compared with pre-procedure	calculated post-treatment (1 hr).
Primary	Change in average heart rate	Difference between average heart rate during procedure compared with pre-procedure	calculated post-treatment (1 hr).
Secondary	Change is STAI score	Measure change in Stait-Trait anxiety inventory State 5 question score pre and post-procedure.	calculated post-procedure (1 hr).
Secondary	Pain catastrophizing score	Pain catastrophizing score	calculated pre-procedure (1 hr).
Secondary	Patient satisfaction	Likert scale rating of satisfaction of treatment group	measured post-treatment (1 hr).