Virtual Reality in Laryngology

NCT ID: NCT05218967

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-14

Study Completion Date

2022-08-08

Brief Summary

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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

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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.

Conditions

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Pain Management During Office Laryngeal Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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In-office procedure with VR-assistance

Group Type EXPERIMENTAL

Virtual Reality Headset

Intervention Type 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 without VR-assistance

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anais Rameau, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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20-01021300

Identifier Type: -

Identifier Source: org_study_id

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