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Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing

Not Applicable
Completed
Conditions
Overactive Bladder
Stress Incontinence, Female
Lower Urinary Tract Symptoms
Interventions
Behavioral: Mindfulness exercises
Registration Number
NCT03625843
Lead Sponsor
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?

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
27
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Mindfullness exercisesMindfulness exercisesParticipate 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.
Primary Outcome Measures
NameTimeMethod
Anxiety during urodynamics as measured the STAI-6.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
NameTimeMethod
Pain as measured by the VASDay 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.

Positive and negative emotions as measured by the urodynamic questionnaireDay 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.

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