Condition category
Signs and Symptoms
Date applied
25/04/2018
Date assigned
08/05/2018
Last edited
09/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Urodynamic study (UDS) is a series of tests that evaluate bladder and urethral function. UDS involves placing catheters into the bladder and rectum that can be uncomfortable. Several interventions have been attempted to reduce the unpleasantness associated with UDS without success. A new technique that has been shown to reduce chronic bladder pain is mindfulness. The aim of this study is to see whether incorporating mindfulness exercises before UDS results in less pain, anxiety and discomfort.

Who can participate?
Patients aged 18-80 scheduled to undergo UDS for urinary symptoms

What does the study involve?
Participants are randomly allocated to one of two treatment plans. One treatment plan includes undergoing mindfulness exercises before the UDS evaluation. Participants are guided through a mindfulness meditation exercise by a licensed professional where they are asked to focus their attention on their breathing, physical sensations, and thoughts. This exercise lasts for about 10 minutes and does not involve any physical activity other than sitting and breathing. The other treatment plan includes simply undergoing the UDS evaluation. After the UDS evaluation, participants are asked questions about their emotional and physical experiences during the UDS procedure, including pain, anxiety and discomfort.

What are the possible benefits and risks of participating?
Participants may experience less discomfort, anxiety and/or pain associated with UDS. There is no guarantee they will receive any benefit from this study other than knowing that the information may help future patients.

Where is the study run from?
Brooke Army Medical Center (USA)

When is the study starting and how long is it expected to run for?
September 2016 to April 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Forrest Jellison

Trial website

Contact information

Type

Public

Primary contact

Dr Forrest Jellison

ORCID ID

Contact details

Division of Urology
3551 Roger Brooke Dr
Fort Sam Houston
78234
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C.2016.202d-IRB approval number

Study information

Scientific title

Incorporation of mindfulness exercises to reduce anxiety and pain during urodynamic testing: a pilot randomized controlled trial

Acronym

Study hypothesis

The objective of the study is to investigate whether mindfulness techniques improve patient’s perceptions of UDS testing:
Objective 1: To evaluate changes in anxiety symptoms during UDS testing
Hypothesis: Anxiety will improve during UDS testing with prior mindfulness intervention
Objective 2: To evaluate changes in pain intensity during UDS testing
Hypothesis: Pain will improve during UDS testing with prior mindfulness intervention

Ethics approval

Regional Health Command-Central (RHC-C) Institutional Review Board, 29/09/2016, Protocol C.2016.202d

Study design

Single-center randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Urodynamic, urinary incontinence, anxiety, physical discomfort

Intervention

This a single center randomized trial with the urologist performing the urodynamic testing blinded or masked. Participants are randomly assigned to one of two treatment plans. One treatment plan includes undergoing mindfulness exercises prior to the UDS evaluation. Participants are guided through a mindfulness meditation exercise by a licensed professional where they are asked to focus their attention on their breathing, physical sensations, and thoughts. This exercise will last for approximately 10 minutes in which participants will not be asked to engage in any physical activity other than sitting and breathing. The other treatment plan includes simply undergoing the UDS evaluation. After the UDS evaluation, participants will be asked questions about the urodynamic procedure. They will be asked to answer questions on a UDS and anxiety questionnaire which pertain to their emotional and physical experiences during the procedure. They will rate the amount of discomfort on a scale of 1-10 during the procedure on a visual analog pain scale.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Anxiety as measured by state-trait anxiety inventory (STAI-6). The STAI-6 form consists of six feelings, negative feelings (tense, upset, worried) and positive feelings (calm, relaxed, content), that are measured with a Likert scale. Higher scores are associated with higher levels of anxiety. Measured three times during the same clinic visit for UDS testing: at baseline, about 10 min later, and after the UDS testing.

Secondary outcome measures

Measured three times during the same clinic visit for UDS testing: at baseline, about 10 min later, and after the UDS testing:
1. Pain as measured on the visual analog scale
2. Emotional and physical discomfort as measured by a urodynamic questionnaire

Overall trial start date

29/09/2016

Overall trial end date

18/04/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Adults (Department of Defense [DoD] beneficiaries and active duty military patients aged 18-80) scheduled for urodynamic testing

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Age less than 18 years
2. Pregnant, as verified by urine or blood sample
3. Have an alteration in neurologic bladder function
4. Inability to complete forms
5. Inability to provide informed consent

Recruitment start date

01/09/2017

Recruitment end date

30/12/2018

Locations

Countries of recruitment

United States of America

Trial participating centre

Brooke Army Medical Center
San Antonio
78234
United States of America

Sponsor information

Organisation

Brooke Army Medical Center

Sponsor details

3551 Roger Brooke Dr
Fort Sam Houston
78234
United States of America

Sponsor type

Government

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plan to submit for publication by June 2018.

IPD sharing statement
The data that is stored is de-identified from the validated questionnaires and demographic information.

Intention to publish date

01/06/2018

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/05/2018: Internal review.