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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-office procedure with VR-assistance | Experimental |
| |
| In-office procedure without VR-assistance | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Headset | Other | A head-worn apparatus that completely covers the eyes for an immersive 3D experience. The VR headset will be worn during the procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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. | 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). | Immediately After Procedure |
| Heart rate | Heart rate will will be measured through AD instruments PowerLab. | Measures will be recorded immediately before and immediately after the procedure. |
| Temperature | Temperature will be measured through AD instruments PowerLab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anais Rameau, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10021 | United States |
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| Measures will be recorded immediately before and immediately after the procedure. |
| Galvanic Skin Activity | Galvanic Skin Activity will be measured through AD instruments PowerLab | 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. | 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 | During the Procedure |