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Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing

S

San Antonio Uniformed Services Health Education Consortium

Status

Completed

Conditions

Lower Urinary Tract Symptoms
Stress Incontinence, Female
Overactive Bladder

Treatments

Behavioral: Mindfulness exercises

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT03625843
c.2016.202d

Details and patient eligibility

About

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?

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

27 participants in 2 patient groups

Mindfullness exercises
Experimental group
Description:
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.
Treatment:
Behavioral: Mindfulness exercises
Control
No Intervention group
Description:
Sitting quietly in a room alone.

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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