Virtual Reality (VR) During Peripheral Nerve Evaluation (PNE) Procedure

Study Overview
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Brief Summary
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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).

Official Title
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Decreasing Intraprocedural Peripheral Nerve Evaluation (PNE) Pain and Anxiety Using the SmileyScope Virtual Reality

Conditions
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Overactive Bladder

Intervention / Treatment
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* Device: SmileyScope VR
* Other: Standard of Care Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SmileyScope VR Group<br>Participants in this group will wear the SmileyScope VR set during the PNE procedure for approximately 40 minutes. | Device: SmileyScope VR<br>* 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.<br>|
| Experimental: No VR Group<br>Participants in this group will receive standard of care treatment. | Other: Standard of Care Treatment<br>* Participants in this group will receive standard of care treatment during an in-person, one time PNE procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |