Clinical trial NCT05218967: Virtual Reality in Laryngology
Official title: Virtual Reality as a Distraction Intervention for Pain Management During Office Laryngeal Procedures: Randomized Single Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management During Office Laryngeal Procedures
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain during procedure, as measured by the McGill Pain Questionnaire
timeFrame: During Procedure
measure: Anxiety during the procedure , as measured by the spielberger State-Trait Anxiety Inventory (SF- STAI)
timeFrame: During Procedure
measure: Post Procedure Patient Questionnaire
timeFrame: Immediately After Procedure
measure: Physician Questionnaire
timeFrame: Immediately After Procedure
measure: Heart rate
timeFrame: Measures will be recorded immediately before and immediately after the procedure.
measure: Temperature
timeFrame: Measures will be recorded immediately before and immediately after the procedure.
measure: Galvanic Skin Activity
timeFrame: Measures will be recorded immediately before and immediately after the procedure.
measure: Pain as measured by the Visual Analog Scale
timeFrame: Measures will be recorded immediately after the procedure.
measure: Upper Esophageal Sphincter Pressure
timeFrame: During the Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Anais Rameau, M.D.
role: PRINCIPAL_INVESTIGATOR
References: