Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures
NCT ID: NCT06227039
Last Updated: 2024-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2022-10-01
2024-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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No treatment
This arm will be the current standard of care
No interventions assigned to this group
Vibroacoustic
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.
Vibroacoustic stimulation on
Mechanical stimulus is provided to the patient through a vibroacoustic device via vibration around the neck.
Augmented reality off
Augmented reality glasses are worn but turned off.
Augmented Reality
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.
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.
Combination vibroacoustic and augmented reality
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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University of Virginia
OTHER
Responsible Party
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James Daniero, MD
Associate Professor, Division Director, Laryngology and Voice Care
Principal Investigators
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James J Daniero, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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UVA Fontaine Research Park Building 415
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Braz J, Solorzano C, Wang X, Basbaum AI. Transmitting pain and itch messages: a contemporary view of the spinal cord circuits that generate gate control. Neuron. 2014 May 7;82(3):522-36. doi: 10.1016/j.neuron.2014.01.018.
Treede RD. Gain control mechanisms in the nociceptive system. Pain. 2016 Jun;157(6):1199-1204. doi: 10.1097/j.pain.0000000000000499.
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.
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.
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.
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.
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.
Other Identifiers
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HSR210111
Identifier Type: -
Identifier Source: org_study_id
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