Recruiting

Augmented Reality & Vibratory Array

Sponsor:

University of Virginia

Code:

NCT06227039

Conditions

Pain, Acute

Vocal Fold Polyp

Vocal Cord Paralysis

Laryngeal Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Vibroacoustic stimulation on

Augmented Reality on

Vibroacoustic stimulation off

Augmented reality off

Study Details

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

Study ID

NCT06227039

Start date

Oct 1, 2022

Status verified date

Jan, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: No treatment

This arm will be the current standard of care

experimental: 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.

experimental: 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.

experimental: 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.

Interventions

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.

Primary outcome measure

  • Max pain experienced [ Time Frame: measured post-treatment (1 hr). ]
  • Average pain experienced [ Time Frame: measured post-treatment (1 hr). ]
  • Pain nervousness experienced [ Time Frame: measured post-treatment (1 hr). ]
  • Time spent thinking about pain [ Time Frame: measured post-treatment (1 hr). ]
  • Change in heart rate variability during procedure [ Time Frame: calculated post-treatment (1 hr). ]
  • Change in maximum heart rate [ Time Frame: calculated post-treatment (1 hr). ]
  • Change in average heart rate [ Time Frame: calculated post-treatment (1 hr). ]

Central Contacts and Locations

Central contacts

James J Daniero, MD

4349242040jjd5h@uvahealth.org

Elena Miller, MPH

4342433607em8zk@uvahealth.org

Locations

UVA Fontaine Research Park Building 415

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

James Daniero, MD

434-924-2040jjd5h@uvahealth.org

Principal Investigator:

James Daniero, MD

More Information

Sponsor

University of Virginia

Last update posted

Jan 26, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2024-01-26.