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

NCT ID: NCT05928910

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-30
• Study Completion Date: 2025-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SmileyScope VR Group

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

Group Type: EXPERIMENTAL

SmileyScope VR

Intervention Type: 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.

No VR Group

Participants in this group will receive standard of care treatment.

Group Type: EXPERIMENTAL

Standard of Care Treatment

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Standard of Care Treatment

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Raveen Syan

Assistant Professor of Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raveen Syan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Other Identifiers

20230398

Identifier Type: -

Identifier Source: org_study_id