Virtual Reality in Laryngology

Virtual Reality as a Distraction Intervention for Pain Management During Office Laryngeal Procedures: Randomized Single Blinded Clinical Trial

The purpose of this study is to compare patient's pain and anxiety undergoing laryngeal procedures and esophageal manometry while wearing a VR headset to standard of care. It is hypothesized that patient's using the VR headset during the procedure will have reduced pain and anxiety as compared to their standard of care counterparts because the VR environment will distract them from their procedure.

Study Overview

• Status: Completed
• Conditions: Pain Management During Office Laryngeal Procedures
• Intervention / Treatment: Other: Virtual Reality Headset

Detailed Description

This is a prospective randomized controlled trial, comparing patients' pain and anxiety experience while wearing a VR headset and receiving standard analgesia during In-office aerodigestive procedures (IOAEP) to patients' experience receiving standard analgesia only during IOAEP.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hal D Rives, B.S.; Phone Number: 16469629883; Email: har4001@med.cornell.edu
• Study Contact Backup: Name: Ilan Palte, M.D.; Phone Number: 404.805.5786; Email: icp4001@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients (18 or older)
• Patients scheduled for IOAEP, including laryngeal biopsies, percutaneous injection laryngoplasty, KTP ablation of hemorrhagic polyps and respiratory papilloma, and transnasal esophagoscopy (TNE), and esophageal manometry.

Exclusion Criteria:

• Patients under 18 years of age
• Patients unable to consent
• Non-English-speaking patients
• Patients who have undergone prior IOAEP
• Patients who have used any psychotropic or analgesic medication within the last 24 hours due to the possible confounding effect on pain or anxiety perception
• Patients with motion sickness or uncorrected visual impairment (legal blindness)
• Patients with past medical history of seizures or visual abnormalities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In-office procedure with VR-assistance	Other: Virtual Reality Headset; A head-worn apparatus that completely covers the eyes for an immersive 3D experience. The VR headset will be worn during the procedure.
No Intervention: In-office procedure without VR-assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during procedure, as measured by the McGill Pain Questionnaire	individually rated pain descriptors with 11 addressing sensory pain and 4 focusing on affective components of pain. Each item is rated on a 4-point scale that ranges from none to severe.	During Procedure
Anxiety during the procedure , as measured by the spielberger State-Trait Anxiety Inventory (SF- STAI)	The STAI consists of 6 questions concerning patient's current state of anxiety with responses ranging from (1) never to almost always (4).	During Procedure
Post Procedure Patient Questionnaire	Patients will be asked if they would repeat the procedure again on a scale of 1-5 with 1 being never and 5 being always.	Immediately After Procedure
Physician Questionnaire	Clinicians will fill out a short 6 question survey about the use of VR during their procedure. The survey is a short 6 item questionnaire inquiring about difficulty and success of the procedure, perceived patients' discomfort, observed patient agitation, interference and benefit of the VR headset. These questions will be answered using a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).	Immediately After Procedure
Heart rate	Heart rate will will be measured through AD instruments PowerLab.	Measures will be recorded immediately before and immediately after the procedure.
Temperature	Temperature will be measured through AD instruments PowerLab	Measures will be recorded immediately before and immediately after the procedure.
Galvanic Skin Activity	Galvanic Skin Activity will be measured through AD instruments PowerLab	Measures will be recorded immediately before and immediately after the procedure.
Pain as measured by the Visual Analog Scale	Visual Analog Pain Scale measured pain on range from 0-100 (0 is no pain and 100 is max pain) about time of pain, unpleasantness, average pain, and worst pain on a scale of 0-100.	Measures will be recorded immediately after the procedure.
Upper Esophageal Sphincter Pressure	Upper Esophageal Sphincter Pressure will be measured through the probe inserted during the High Resolution Manometry	During the Procedure

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Anais Rameau, M.D., Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): August 8, 2022
• Study Completion (Actual): August 8, 2022

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20-01021300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No