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Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing

Primary Purpose

Stress Incontinence, Female, Overactive Bladder, Lower Urinary Tract Symptoms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness exercises
Sponsored by
San Antonio Uniformed Services Health Education Consortium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Incontinence, Female focused on measuring urodynamics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical diagnosis of urinary symptoms requiring urodynamic testing

    • Stress incontinence
    • Mixed incontinence
    • Urge incontinence
    • Overactive bladder
    • Urinary retention
    • Lower urinary tract symptoms
  • Are Department of Defense (DoD) beneficiaries

Exclusion Criteria:

  • Neurogenic bladder
  • Interstitial cystitis
  • Chronic bladder pain
  • Inability to have urodynamics performed
  • Are Not DoD beneficiaries
  • Pregnant
  • Lack capacity to consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Mindfullness exercises

    Control

    Arm Description

    Participate in mindfulness exercises prior to urodynamic studies (UDS). As a participant, you will be guided through a mindfulness meditation exercise by a licensed professional. During this exercise you will be asked to focus your attention on your breathing, physical sensations, and thoughts. This exercise will last for approximately 10 minutes.

    Sitting quietly in a room alone.

    Outcomes

    Primary Outcome Measures

    Anxiety during urodynamics as measured the STAI-6.
    The STAI-6, State Trait Anxiety Inventory, is a validated questionnaire that measures anxiety. The total score from the STAI-6 will be used with a range of score from 4-24. Higher scores indicate higher level of anxiety.

    Secondary Outcome Measures

    Positive and negative emotions as measured by the urodynamic questionnaire
    The urodynamic questionnaire is clinically validated with participants self-reporting emotions fear, discomfort, embarrassment, and if the test was better or worse than expected. The questions are analyzed individually with score ranked on a likert scale of 1-4. Higher score indicate higher levels of that particular emotion.
    Pain as measured by the VAS
    The visual analog scale (VAS) for pain total score will be recorded. The minimum and Maximum scores range from 1-10. Higher scores indicate more pain.

    Full Information

    First Posted
    July 25, 2018
    Last Updated
    August 9, 2018
    Sponsor
    San Antonio Uniformed Services Health Education Consortium
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03625843
    Brief Title
    Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing
    Official Title
    Incorporation of Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    September 29, 2016 (Actual)
    Primary Completion Date
    December 30, 2017 (Actual)
    Study Completion Date
    April 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    San Antonio Uniformed Services Health Education Consortium

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In this pilot study the investigators attempt to answer the question, does mindfulness exercises before urodynamic testing reduce patient's perception of anxiety or pain?
    Detailed Description
    The subjects are being asked to consider participation in this research study. The purpose of this study is to see if incorporating mindfulness exercises prior to urodynamic studies (UDS) results in less pain, anxiety and discomfort. The participants will be guided through a mindfulness meditation exercise by a licensed professional. During this exercise participants will be asked to focus attention on breathing, physical sensations, and thoughts. This exercise will last for approximately 10 minutes in which participants will not be asked to engage in any physical activity other than sitting and breathing. The participants will be randomly assigned to one of 2 treatment plans. Randomization is a process like flipping a coin and means the chance of being assigned to either of the plans. One treatment plan includes undergoing mindfulness exercises prior to your UDS evaluation. The other treatment plan includes simply undergoing the UDS evaluation. After the participants UDS evaluation, questions will be asked about the urodynamic procedure. The participants will be asked to answer questions on a UDS and anxiety questionnaire which pertain to emotional and physical experiences during the procedure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress Incontinence, Female, Overactive Bladder, Lower Urinary Tract Symptoms
    Keywords
    urodynamics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mindfullness exercises
    Arm Type
    Experimental
    Arm Description
    Participate in mindfulness exercises prior to urodynamic studies (UDS). As a participant, you will be guided through a mindfulness meditation exercise by a licensed professional. During this exercise you will be asked to focus your attention on your breathing, physical sensations, and thoughts. This exercise will last for approximately 10 minutes.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Sitting quietly in a room alone.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness exercises
    Primary Outcome Measure Information:
    Title
    Anxiety during urodynamics as measured the STAI-6.
    Description
    The STAI-6, State Trait Anxiety Inventory, is a validated questionnaire that measures anxiety. The total score from the STAI-6 will be used with a range of score from 4-24. Higher scores indicate higher level of anxiety.
    Time Frame
    Day 1
    Secondary Outcome Measure Information:
    Title
    Positive and negative emotions as measured by the urodynamic questionnaire
    Description
    The urodynamic questionnaire is clinically validated with participants self-reporting emotions fear, discomfort, embarrassment, and if the test was better or worse than expected. The questions are analyzed individually with score ranked on a likert scale of 1-4. Higher score indicate higher levels of that particular emotion.
    Time Frame
    Day 1
    Title
    Pain as measured by the VAS
    Description
    The visual analog scale (VAS) for pain total score will be recorded. The minimum and Maximum scores range from 1-10. Higher scores indicate more pain.
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of urinary symptoms requiring urodynamic testing Stress incontinence Mixed incontinence Urge incontinence Overactive bladder Urinary retention Lower urinary tract symptoms Are Department of Defense (DoD) beneficiaries Exclusion Criteria: Neurogenic bladder Interstitial cystitis Chronic bladder pain Inability to have urodynamics performed Are Not DoD beneficiaries Pregnant Lack capacity to consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Forrest C Jellison, MD
    Organizational Affiliation
    San Antonio Uniformed Services Health Education Consortium
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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