An interventional study of Mindfulness meditation in Personal Satisfaction, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-15.
Sponsored by Loma Linda University · Not applicable, Interventional, and Supportive care
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).
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.
Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
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Exclusion Criteria:
Those in the mindfulness medication group will listen to an audio-taped mediation, which takes 10 mins to complete.
Behavioral: Mindfulness meditation
The control group will be seated in a quiet empty room where they wait for 10 min.
Behavioral: Mindfulness meditation
Mindfulness meditation
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.
Time frame: 1 year
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.
Time frame: 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.
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Loma Linda University