Virtual Reality in Laryngology

Not Applicable

Completed

• Conditions: Pain Management During Office Laryngeal Procedures

• Registration Number: NCT05218967
• Lead Sponsor: Weill Medical College of Cornell University

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.

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 Timeline

• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-02-01
• Study Start: 2022-02-14
• Primary Completion: 2022-08-08
• Study Completion: 2022-08-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physician Questionnaire	Immediately After Procedure	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).
Galvanic Skin Activity	Measures will be recorded immediately before and immediately after the procedure.	Galvanic Skin Activity will be measured through AD instruments PowerLab
Anxiety during the procedure , as measured by the spielberger State-Trait Anxiety Inventory (SF- STAI)	During Procedure	The STAI consists of 6 questions concerning patient's current state of anxiety with responses ranging from (1) never to almost always (4).
Pain during procedure, as measured by the McGill Pain Questionnaire	During Procedure	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.
Heart rate	Measures will be recorded immediately before and immediately after the procedure.	Heart rate will will be measured through AD instruments PowerLab.
Temperature	Measures will be recorded immediately before and immediately after the procedure.	Temperature will be measured through AD instruments PowerLab
Pain as measured by the Visual Analog Scale	Measures will be recorded immediately after the procedure.	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.
Upper Esophageal Sphincter Pressure	During the Procedure	Upper Esophageal Sphincter Pressure will be measured through the probe inserted during the High Resolution Manometry
Post Procedure Patient Questionnaire	Immediately After Procedure	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.

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States