Clinical trial NCT04446143: Effects on Mindfulness Meditation on Patient's Satisfaction During Urodynamic Study
Official title: Effects of Mindfulness Meditation on Patients' Satisfaction During Urodynamic Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Personal Satisfaction
Keywords: meditation, urodynamics, satisfaction, pain, anxiety
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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
* Prioners

Primary outcomes:
measure: Satisfaction during the urodynamic study testing
timeFrame: 1 year
Secondary outcomes:
measure: Self evaluation of anxiety and comfort level
timeFrame: 1 year
measure: Pain level
timeFrame: 1 year
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Faculty Medical Offices
state: California
Study officials:
affiliation: Loma Linda Univ Health
name: Andrea Staack
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uberoi P, Smitherman A, Aden J, Park G, Jellison F. Incorporation of Mindfulness Exercises to Reduce Anxiety During Urodynamic Testing: A Randomized Single-Blind Controlled Pilot Trial. J Altern Complement Med. 2020 Jan;26(1):74-75. doi: 10.1089/acm.2018.0447. Epub 2019 Sep 25. No abstract available.