An interventional study of Virtual Reality Headset in Pain Management During Office Laryngeal Procedures, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Other
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.
Weill Medical College of Cornell University is the lead sponsor of 867 studies on the registry; 160 are open to participants now.
Of its 119 completed or terminated interventional studies of FDA-regulated products, 91 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: 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.
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
Galvanic Skin Activity will be measured through AD instruments PowerLab
Time frame: 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.
Time frame: 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
Time frame: During the Procedure
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University