Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing

Study Overview
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Brief Summary
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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
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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.

Official Title
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Incorporation of Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing: a Randomized Controlled Trial

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

Intervention / Treatment
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* Behavioral: Mindfulness exercises


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfullness exercises<br>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<br> <br> |
| No Intervention: Control<br>Sitting quietly in a room alone. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 
| 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. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urodynamics