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Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures

NCT06227039 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-01-26

No results posted yet for this study

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

Interventions

OTHER

Vibroacoustic stimulation on

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

OTHER

Augmented Reality on

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

OTHER

Vibroacoustic stimulation off

Vibroacoustic device is worn but turned off.

OTHER

Augmented reality off

Augmented reality glasses are worn but turned off.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • James J Daniero, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06227039 on ClinicalTrials.gov