Virtual Reality in Laryngology

NCT05218967 | Completed

• 1 other identifier: 20-01021300
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Management During Office Laryngeal Procedures

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

In-office procedure with VR-assistance

EXPERIMENTAL

Other: Virtual Reality Headset

In-office procedure without VR-assistance

NO INTERVENTION

Interventions

Virtual Reality Headset OTHER

A head-worn apparatus that completely covers the eyes for an immersive 3D experience. The VR headset will be worn during the procedure.

In-office procedure with VR-assistance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Study Officials

• Anais Rameau, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 1, 2022
• Study Start: February 14, 2022
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)