Overactive Bladder
Conditions
Brief summary
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).
Interventions
DEVICESmileyScope VR
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.
OTHERStandard of Care Treatment
Participants in this group will receive standard of care treatment during an in-person, one time PNE procedure.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients undergoing elective peripheral nerve evaluation studies for pelvic floor dysfunction
Exclusion criteria
* Have a serious comorbid illness or condition that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study * Significant refractive error, unilateral blindness, epilepsy, or other conditions such as skin infections, cancers, etc., which could compromise the physical function of the headset
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change In Pain as Measured by Numeric Pain Scale | Baseline (pre-PNE procedure), up to 1 hour (post-PNE procedure) | Pain will be measured using the numeric pain scale. Scores range from 0-10. Higher scores indicate worse pain. |
| Change in Anxiety as Measured by State Trait Anxiety Inventory | Baseline (pre-PNE procedure), up to 1 hour (post-PNE procedure) | Anxiety will be measured using the State Trait Anxiety Inventory. Scores range from 0-24. Higher scores indicate greater anxiety. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility for the Utilization of the Smiley Scope VR Headset by Likert Scale | up to one hour post-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. |
| Satisfaction with Procedure as measured by Likert Scale | up to one hour post-procedure | 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. |
Outcome results
None listed