Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing

NCT03625843 | Completed

• 1 other identifier: c.2016.202d
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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?

Conditions

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

Keywords

urodynamics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Positive and negative emotions as measured by the urodynamic questionnaire

  Day 1

• Pain as measured by the VAS

  Day 1

Study Arms (2)

Mindfullness exercises

EXPERIMENTAL

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

Control

NO INTERVENTION

Sitting quietly in a room alone.

Interventions

Mindfulness exercises BEHAVIORAL

Mindfullness exercises

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Neurogenic bladder
• Interstitial cystitis
• Chronic bladder pain
• Inability to have urodynamics performed
• Are Not DoD beneficiaries
• Pregnant
• Lack capacity to consent

Sponsors & Collaborators

• San Antonio Uniformed Services Health Education Consortium: lead

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Bladder, Overactive; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Study Officials

• Forrest C Jellison, MD

  San Antonio Uniformed Services Health Education Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 10, 2018
• Study Start: September 29, 2016
• Primary Completion: December 30, 2017
• Study Completion: April 30, 2018
• Last Updated: August 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share