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

NCT ID: NCT04446143

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-07-15

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.

Conditions

Personal Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Mindfulness meditation

Intervention Type: BEHAVIORAL

Mindfulness meditation

No meditation prior to UDS

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

Group Type: ACTIVE_COMPARATOR

Mindfulness meditation

Intervention Type: BEHAVIORAL

Mindfulness meditation

Interventions

Mindfulness meditation

Mindfulness meditation

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Staack

Role: PRINCIPAL_INVESTIGATOR

Loma Linda Univ Health

Locations

Loma Linda University Faculty Medical Offices

Loma Linda, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31553223 (View on PubMed)

Other Identifiers

5200230

Identifier Type: -

Identifier Source: org_study_id