Virtual Reality in Laryngology

Weill Medical College of Cornell University40 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pain Management During Office Laryngeal Procedures

Interventions

Virtual Reality HeadsetOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Weill Cornell Medicine

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: 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).

Time frame: Immediately After Procedure

Heart rate

Heart rate will will be measured through AD instruments PowerLab.

Time frame: Measures will be recorded immediately before and immediately after the procedure.

Temperature

Temperature will be measured through AD instruments PowerLab

Time frame: Measures will be recorded immediately before and immediately after the procedure.

Galvanic Skin Activity

Data from ClinicalTrials.gov

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