RECRUITING

Patient Augmented Reality and Vibratory Array Otorhinolaryngology Procedures

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06227039

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients undergoing office-based laryngology procedure performed at home institution.
  1. * None

Contacts and Locations

Study Contact

James J Daniero, MD
CONTACT
4349242040
jjd5h@uvahealth.org
Elena Miller, MPH
CONTACT
4342433607
em8zk@uvahealth.org

Principal Investigator

James J Daniero, MD
PRINCIPAL_INVESTIGATOR
University of Virginia

Study Locations (Sites)

UVA Fontaine Research Park Building 415
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • James J Daniero, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-10-01
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

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