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Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03625843
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Forrest Jellison, San Antonio Uniformed Services Health Education Consortium

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?

Condition or disease Intervention/treatment Phase
Stress Incontinence, Female Overactive Bladder Lower Urinary Tract Symptoms Behavioral: Mindfulness exercises Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Incorporation of Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing: a Randomized Controlled Trial
Actual Study Start Date : September 29, 2016
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfullness exercises
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.
Behavioral: Mindfulness exercises
No Intervention: Control
Sitting quietly in a room alone.



Primary Outcome Measures :
  1. Anxiety during urodynamics as measured the STAI-6. [ Time Frame: Day 1 ]
    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 :
  1. Positive and negative emotions as measured by the urodynamic questionnaire [ Time Frame: Day 1 ]
    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.

  2. Pain as measured by the VAS [ Time Frame: Day 1 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625843


Sponsors and Collaborators
San Antonio Uniformed Services Health Education Consortium
Investigators
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Principal Investigator: Forrest C Jellison, MD San Antonio Uniformed Services Health Education Consortium
  Study Documents (Full-Text)

Documents provided by Forrest Jellison, San Antonio Uniformed Services Health Education Consortium:
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Responsible Party: Forrest Jellison, Principle Investigator, San Antonio Uniformed Services Health Education Consortium
ClinicalTrials.gov Identifier: NCT03625843    
Other Study ID Numbers: c.2016.202d
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Forrest Jellison, San Antonio Uniformed Services Health Education Consortium:
urodynamics
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Incontinence
Urination Disorders