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

University of Miami0 sitesJanuary 30, 2024

ConditionsOveractive Bladder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Overactive Bladder
Sponsor: University of Miami
Primary Endpoint: Change in Anxiety as Measured by State Trait Anxiety Inventory
Status: Withdrawn
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 30, 2024

End Date

November 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Raveen Syan

Assistant Professor of Clinical

University of Miami

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Anxiety as Measured by State Trait Anxiety Inventory

Time Frame: 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.

Change In Pain as Measured by Numeric Pain Scale

Time Frame: 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.

Secondary Outcomes

Satisfaction with Procedure as measured by Likert Scale(up to one hour post-procedure)
Feasibility for the Utilization of the Smiley Scope VR Headset by Likert Scale(up to one hour post-procedure)