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

Primary Purpose

Overactive Bladder

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SmileyScope VR
Standard of Care Treatment
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    SmileyScope VR Group

    No VR Group

    Arm Description

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

    Participants in this group will receive standard of care treatment.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    June 23, 2023
    Last Updated
    October 3, 2023
    Sponsor
    University of Miami
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05928910
    Brief Title
    Virtual Reality (VR) During Peripheral Nerve Evaluation (PNE) Procedure
    Official Title
    Decreasing Intraprocedural Peripheral Nerve Evaluation (PNE) Pain and Anxiety Using the SmileyScope Virtual Reality
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    decided to not proceed with study due to lack of personnel
    Study Start Date
    January 30, 2024 (Anticipated)
    Primary Completion Date
    November 30, 2025 (Anticipated)
    Study Completion Date
    November 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Miami

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overactive Bladder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    SmileyScope VR Group
    Arm Type
    Experimental
    Arm Description
    Participants in this group will wear the SmileyScope VR set during the PNE procedure for approximately 40 minutes.
    Arm Title
    No VR Group
    Arm Type
    Experimental
    Arm Description
    Participants in this group will receive standard of care treatment.
    Intervention Type
    Device
    Intervention Name(s)
    SmileyScope VR
    Intervention Description
    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
    Other
    Intervention Name(s)
    Standard of Care Treatment
    Intervention Description
    Participants in this group will receive standard of care treatment during an in-person, one time PNE procedure.
    Primary Outcome Measure Information:
    Title
    Change In Pain as Measured by Numeric Pain Scale
    Description
    Pain will be measured using the numeric pain scale. Scores range from 0-10. Higher scores indicate worse pain.
    Time Frame
    Baseline (pre-PNE procedure), up to 1 hour (post-PNE procedure)
    Title
    Change in Anxiety as Measured by State Trait Anxiety Inventory
    Description
    Anxiety will be measured using the State Trait Anxiety Inventory. Scores range from 0-24. Higher scores indicate greater anxiety.
    Time Frame
    Baseline (pre-PNE procedure), up to 1 hour (post-PNE procedure)
    Secondary Outcome Measure Information:
    Title
    Satisfaction with Procedure as measured by Likert Scale
    Description
    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.
    Time Frame
    up to one hour post-procedure
    Title
    Feasibility for the Utilization of the Smiley Scope VR Headset by Likert Scale
    Description
    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.
    Time Frame
    up to one hour post-procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Raveen Syan, MD
    Organizational Affiliation
    University of Miami
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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