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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list