Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03625843
• Other study ID #: c.2016.202d
• Status: Completed
• Phase: N/A
• Start date: September 29, 2016
• Est. completion date: April 30, 2018

Study information

• Verified date: August 2018
• Source: San Antonio Uniformed Services Health Education Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 30, 2018
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Mindfulness exercises

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
San Antonio Uniformed Services Health Education Consortium

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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