Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing
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|ClinicalTrials.gov Identifier: NCT03625843|
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stress Incontinence, Female Overactive Bladder Lower Urinary Tract Symptoms||Behavioral: Mindfulness exercises||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Incorporation of Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing: a Randomized Controlled Trial|
|Actual Study Start Date :||September 29, 2016|
|Actual Primary Completion Date :||December 30, 2017|
|Actual Study Completion Date :||April 30, 2018|
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.
- Anxiety during urodynamics as measured the STAI-6. [ Time Frame: Day 1 ]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.
- Positive and negative emotions as measured by the urodynamic questionnaire [ Time Frame: Day 1 ]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.
- Pain as measured by the VAS [ Time Frame: Day 1 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625843
|Principal Investigator:||Forrest C Jellison, MD||San Antonio Uniformed Services Health Education Consortium|