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

Sponsor
Loma Linda University (Other)
Overall Status
Completed
CT.gov ID
NCT04446143
Collaborator
(none)
60
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2
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8.1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness meditation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effects of Mindfulness Meditation on Patients' Satisfaction During Urodynamic Study.
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Jul 15, 2021
Actual Study Completion Date :
Jul 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loma Linda University Faculty Medical Offices Loma Linda California United States 92354

Sponsors and Collaborators

  • Loma Linda University

Investigators

  • Principal Investigator: Andrea Staack, Loma Linda Univ Health

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT04446143
Other Study ID Numbers:
  • 5200230
First Posted:
Jun 24, 2020
Last Update Posted:
Feb 15, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Loma Linda University

Study Results

No Results Posted as of Feb 15, 2022