Skip to main content
Clinical Trials/NCT04446143
NCT04446143
Completed
Not Applicable

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

Loma Linda University1 site in 1 country60 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Personal Satisfaction
Sponsor
Loma Linda University
Enrollment
60
Locations
1
Primary Endpoint
Satisfaction during the urodynamic study testing
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
July 15, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Satisfaction during the urodynamic study testing

Time Frame: 1 year

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.

Secondary Outcomes

  • Self evaluation of anxiety and comfort level(1 year)
  • Pain level(1 year)

Study Sites (1)

Loading locations...

Similar Trials