Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
decided to not proceed with study due to lack of personnel
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research is to evaluate whether or not wearing a virtual reality headset affects pain and anxiety in patients undergoing percutaneous nerve evaluation (PNE).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmileyScope VR Group | Experimental | Participants in this group will wear the SmileyScope VR set during the PNE procedure for approximately 40 minutes. |
|
| No VR Group | Experimental | Participants in this group will receive standard of care treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmileyScope VR | Device | The SmileyScope Virtual Reality Headset is a VR headset to reduce pain and anxiety undergoing medical procedures. The device comes pre-loaded with a static virtual reality scenario. Participants will use the device in person when coming to clinic during an in-person, one time PNE procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Change In Pain as Measured by Numeric Pain Scale | Pain will be measured using the numeric pain scale. Scores range from 0-10. Higher scores indicate worse pain. | Baseline (pre-PNE procedure), up to 1 hour (post-PNE procedure) |
| Change in Anxiety as Measured by State Trait Anxiety Inventory | Anxiety will be measured using the State Trait Anxiety Inventory. Scores range from 0-24. Higher scores indicate greater anxiety. | Baseline (pre-PNE procedure), up to 1 hour (post-PNE procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with Procedure as measured by Likert Scale | Satisfaction with be measured by likert scale. Scores range from (1) very unsatisfied with today's procedure to (5) very satisfied with today's procedure. | up to one hour post-procedure |
| Feasibility for the Utilization of the Smiley Scope VR Headset by Likert Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Raveen Syan, MD | University of Miami | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard of Care Treatment | Other | Participants in this group will receive standard of care treatment during an in-person, one time PNE procedure. |
|
Feasibility will be measured by a 5-point Likert scale for the utilization of the Smiley Scope VR Headset. Scores range from (1) very unhelpful in managing your pain and anxiety associated with the PNE procedure to (5) very helpful in managing your pain and anxiety associated with the PNE procedure. |
| up to one hour post-procedure |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |