Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures

NCT06227039 | Unknown

• 1 other identifier: HSR210111
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• Max pain experienced

  Visual analog scale rating of max perceived pain during procedure

  measured post-treatment (1 hr).

• Average pain experienced

  Visual analog scale rating of average perceived pain during procedure

  measured post-treatment (1 hr).

• Pain nervousness experienced

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

  measured post-treatment (1 hr).

• Time spent thinking about pain

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

  measured post-treatment (1 hr).

• Change in heart rate variability during procedure

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

  calculated post-treatment (1 hr).

• Change in maximum heart rate

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

  calculated post-treatment (1 hr).

• Change in average heart rate

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

  calculated post-treatment (1 hr).

Secondary Outcomes (3)

• Change is STAI score

  calculated post-procedure (1 hr).

• Pain catastrophizing score

  calculated pre-procedure (1 hr).

• Patient satisfaction

  measured post-treatment (1 hr).

Study Arms (4)

No treatment

NO INTERVENTION

This arm will be the current standard of care

Vibroacoustic

EXPERIMENTAL

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.

Other: Vibroacoustic stimulation on; Other: Augmented reality off

Augmented Reality

EXPERIMENTAL

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.

Other: Augmented Reality on; Other: Vibroacoustic stimulation off

Combination vibroacoustic and augmented reality

EXPERIMENTAL

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.

Other: Vibroacoustic stimulation on; Other: Augmented Reality on

Interventions

Vibroacoustic stimulation on OTHER

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

Combination vibroacoustic and augmented reality; Vibroacoustic

Augmented Reality on OTHER

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

Augmented Reality; Combination vibroacoustic and augmented reality

Vibroacoustic stimulation off OTHER

Vibroacoustic device is worn but turned off.

Augmented Reality

Augmented reality off OTHER

Augmented reality glasses are worn but turned off.

Vibroacoustic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

UVA Fontaine Research Park Building 415

Charlottesville, Virginia, 22903, United States

RECRUITING

Related Publications (13)

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  PMID: 30905564 BACKGROUND

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  PMID: 30249445 BACKGROUND

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  PMID: 26817644 BACKGROUND

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MeSH Terms

Conditions

Acute Pain; Vocal Cord Paralysis; Laryngeal Neoplasms

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms

Study Officials

• James J Daniero, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James J Daniero, MD

CONTACT

4349242040; jjd5h@uvahealth.org

Elena Miller, MPH

CONTACT

4342433607; em8zk@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division Director, Laryngology and Voice Care

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: October 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)