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

Not Applicable

Withdrawn

• Conditions: Overactive Bladder
• Interventions: Device: SmileyScope VR; Other: Standard of Care Treatment

• Registration Number: NCT05928910
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-23
• Study First Submitted QC: 2023-06-23
• Study First Posted: 2023-07-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-06
• Study Start: 2024-01-30
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SmileyScope VR Group	SmileyScope VR	Participants in this group will wear the SmileyScope VR set during the PNE procedure for approximately 40 minutes.
No VR Group	Standard of Care Treatment	Participants in this group will receive standard of care treatment.

Primary Outcome Measures

Name	Time	Method
Change in Anxiety as Measured by State Trait Anxiety Inventory	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	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 Outcome Measures

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