Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing

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

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?

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Lower Urinary Tract Symptoms; Stress Incontinence, Female
• Intervention / Treatment: Behavioral: Mindfulness exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: San Antonio Uniformed Services Health Education Consortium
• Investigators: Principal Investigator: Forrest C Jellison, MD, San Antonio Uniformed Services Health Education Consortium

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 29, 2016
• Primary Completion (ACTUAL): December 30, 2017
• Study Completion (ACTUAL): April 30, 2018

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (ACTUAL): August 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: urodynamics
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Bladder, Overactive; Lower Urinary Tract Symptoms; Urinary Incontinence, Stress
• Other Study ID Numbers: c.2016.202d

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No