Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing

NCT ID: NCT03625843

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-29
• Study Completion Date: 2018-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness exercises

Intervention Type: BEHAVIORAL

Control

Sitting quietly in a room alone.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness exercises

Intervention Type: BEHAVIORAL

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
• Pregnant
• Lack capacity to consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

San Antonio Uniformed Services Health Education Consortium

FED

Sponsor Role: lead

Responsible Party

Forrest Jellison

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Forrest C Jellison, MD

Role: PRINCIPAL_INVESTIGATOR

San Antonio Uniformed Services Health Education Consortium

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

c.2016.202d

Identifier Type: -

Identifier Source: org_study_id