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

Loma Linda University (LLU)

Status: Completed

Conditions: Personal Satisfaction

Treatments: Behavioral: Mindfulness meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT04446143

5200230

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Application of mindfulness meditation prior to UDS

Other group

Description:

Those in the mindfulness medication group will listen to an audio-taped mediation, which takes 10 mins to complete.

Treatment:

Behavioral: Mindfulness meditation

No meditation prior to UDS

Active Comparator group

Description:

The control group will be seated in a quiet empty room where they wait for 10 min.

Treatment:

Behavioral: Mindfulness meditation