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

University of Miami

Status: Withdrawn

Conditions: Overactive Bladder

Treatments: Other: Standard of Care Treatment; Device: SmileyScope VR

Study type: Interventional

Funder types: Other

Identifiers

NCT05928910

20230398

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

SmileyScope VR Group

Experimental group

Description:

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

Treatment:

Device: SmileyScope VR

No VR Group

Experimental group

Description:

Participants in this group will receive standard of care treatment.

Treatment:

Other: Standard of Care Treatment