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Clinical Trials/NCT03625843
NCT03625843
Completed
Not Applicable

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

San Antonio Uniformed Services Health Education Consortium0 sites27 target enrollmentSeptember 29, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Incontinence, Female
Sponsor
San Antonio Uniformed Services Health Education Consortium
Enrollment
27
Primary Endpoint
Anxiety during urodynamics as measured the STAI-6.
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 29, 2016
End Date
April 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
San Antonio Uniformed Services Health Education Consortium
Responsible Party
Principal Investigator
Principal Investigator

Forrest Jellison

Principle Investigator

San Antonio Uniformed Services Health Education Consortium

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
  • Lack capacity to consent

Outcomes

Primary Outcomes

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 Outcomes

  • Pain as measured by the VAS(Day 1)
  • Positive and negative emotions as measured by the urodynamic questionnaire(Day 1)

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