Clinical Trials Directory

Trials / Completed

CompletedNCT04446143

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Loma Linda University · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMindfulness meditationMindfulness meditation

Timeline

Start date
2020-12-01
Primary completion
2021-07-15
Completion
2021-07-15
First posted
2020-06-24
Last updated
2022-02-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04446143. Inclusion in this directory is not an endorsement.