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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05928910
• Other study ID #: 20230398
• Status: Withdrawn
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: October 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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.

Other:
• Standard of Care Treatment
Participants in this group will receive standard of care treatment during an in-person, one time PNE procedure.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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
Secondary	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