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

NCT05928910 | Withdrawn FDA Device

• 1 other identifier: 20230398
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

SmileyScope VR Group

EXPERIMENTAL

Participants in this group will wear the SmileyScope VR set during the PNE procedure for approximately 40 minutes.

Device: SmileyScope VR

No VR Group

EXPERIMENTAL

Participants in this group will receive standard of care treatment.

Other: Standard of Care Treatment

Interventions

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.

SmileyScope VR Group

Standard of Care Treatment OTHER

Participants in this group will receive standard of care treatment during an in-person, one time PNE procedure.

No VR Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing elective peripheral nerve evaluation studies for pelvic floor dysfunction

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raveen Syan, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: January 30, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share