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
About this trial
This is an interventional treatment trial for Stress Incontinence, Female focused on measuring urodynamics
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
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
NCT ID
NCT03625843
First Posted
July 25, 2018
Last Updated
August 9, 2018
Sponsor
San Antonio Uniformed Services Health Education Consortium
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
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Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing
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