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

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: SmileyScope VR; Other: Standard of Care Treatment

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Raveen Syan, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: June 23, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive
• Other Study ID Numbers: 20230398

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No