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

Not Applicable

Completed

• Conditions: Personal Satisfaction
• Interventions: Behavioral: Mindfulness meditation

• Registration Number: NCT04446143
• Lead Sponsor: Loma Linda University

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 Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-24
• Study Start: 2020-12-01
• Primary Completion: 2021-07-15
• Study Completion: 2021-07-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Application of mindfulness meditation prior to UDS	Mindfulness meditation	Those in the mindfulness medication group will listen to an audio-taped mediation, which takes 10 mins to complete.
No meditation prior to UDS	Mindfulness meditation	The control group will be seated in a quiet empty room where they wait for 10 min.

Primary Outcome Measures

Name	Time	Method
Satisfaction during the urodynamic study testing	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 Outcome Measures

Name	Time	Method
Self evaluation of anxiety and comfort level	1 year	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.
Pain level	1 year	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.

Trial Locations

Locations (1)

Loma Linda University Faculty Medical Offices; 🇺🇸 Loma Linda, California, United States