Effects on Mindfulness Meditation on Patient's Satisfaction During Urodynamic Study

Study Overview
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Brief Summary
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The purpose of this investigator-initiated study is to evaluate if mindfulness-based stress reduction (MBSR) will improve satisfaction and reduce anxiety during a urodynamic study (UDS).

Detailed Description
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Urodynamic studies (UDS) are used to measure the functionality of the bladder and urethra to be able to evaluate lower urinary tract symptoms (LUTS). UDS consists of catheterization, uroflow and cystometrogram. Intravesical, vaginal or rectal transducer placements, and placement of perineal electrodes are part of the study protocol. During the study the bladder will be filled slowly with sterile fluid and the patient will be asked about sensation of filling. At the end of the study the patient will be asked to void. Although beneficial for diagnosis of underlying LUTS, UDS maybe associated with heightened patient anxiety and feeling of discomfort. In a recently published pilot study, it was shown that a mindfulness-based stress reduction (MBSR) protocol may help improve a patient's emotional health and perception of UDS. To validate the findings from this previous study, the current study aims to implement a MBSR protocol in a randomized prospective study. Patients scheduled for UDS will be randomized into two groups. One group will listen to mindfulness meditation prior to the UDS and the other group won't. All patients will complete validated questionnaires to assess their satisfaction, anxiety and pain level as well as lower urinary tract symptoms before and after intervention.

Official Title
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Effects of Mindfulness Meditation on Patients' Satisfaction During Urodynamic Study.

Conditions
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Personal Satisfaction

Intervention / Treatment
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* Behavioral: Mindfulness meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female and male patients between ages 18 and 99 with clinical indication for UDS ordered by treating physician Exclusion Criteria: None English speakers will be recruited for this study. Pregnancy Prioners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subject randomization will use permutated blocks and assignments in concealed consecutively numbered envelops. Those in the mindfulness medication group will listen to an audio-taped mediation, which takes 10 mins to complete, where as the control group will be seated in a quiet empty room where they wait for 10 min.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Application of mindfulness meditation prior to UDS<br>Those in the mindfulness medication group will listen to an audio-taped mediation, which takes 10 mins to complete. | Behavioral: Mindfulness meditation<br>* Mindfulness meditation<br>|
| Active Comparator: No meditation prior to UDS<br>The control group will be seated in a quiet empty room where they wait for 10 min. | Behavioral: Mindfulness meditation<br>* Mindfulness meditation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction during the urodynamic study testing | Likert scale will measure satisfaction with urodynamics in both groups. The scale ranges are: very dissatisfied=0, dissatisfied=1, somehow satisfied=2, satisfied=3, very satisfied=4), with 0 as the worse outcome. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self evaluation of anxiety and comfort level | The State-Trait Anxiety Inventory (STAI 6) score will be obtained before and after the study. It measures stress and anxiety. It ranges from: not al all=1, somewhat=2, moderately so=3, very much so=4), with 4 as the worse outcome. | 1 year | 
| Pain level | The visualised analog pain score (VAS) will be obtained before and after the study. It measure the degree of pain and a range between 0-10 (0=no pain et all and 10=worst pain ever), with 10 as the worse outcome. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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meditation, urodynamics, satisfaction, pain, anxiety