Effects of Mindfulness Meditation on Patients' Satisfaction During Urodynamic Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Loma Linda University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Satisfaction during the urodynamic study testing
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Application of mindfulness meditation prior to UDS
Those in the mindfulness medication group will listen to an audio-taped mediation, which takes 10 mins to complete.
Intervention: Mindfulness meditation (Behavioral)
No meditation prior to UDS
The control group will be seated in a quiet empty room where they wait for 10 min.
Intervention: Mindfulness meditation (Behavioral)
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)