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

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

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).

Study Overview

• Status: Completed
• Conditions: Personal Satisfaction
• Intervention / Treatment: Behavioral: Mindfulness meditation

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Faculty Medical Offices

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 year

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Andrea Staack, Loma Linda Univ Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2020
• Primary Completion (ACTUAL): July 15, 2021
• Study Completion (ACTUAL): July 15, 2021

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (ACTUAL): June 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: meditation, urodynamics, satisfaction, pain, anxiety
• Other Study ID Numbers: 5200230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No