Do mindfulness exercises improve patient experience during urodynamic testing?
| ISRCTN | ISRCTN17581455 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17581455 |
| Secondary identifying numbers | C.2016.202d-IRB approval number |
- Submission date
- 25/04/2018
- Registration date
- 08/05/2018
- Last edited
- 09/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
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
Contact information
Public
Division of Urology
3551 Roger Brooke Dr
Fort Sam Houston
78234
United States of America
Study information
| Study design | Single-center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Incorporation of mindfulness exercises to reduce anxiety and pain during urodynamic testing: a pilot randomized controlled trial |
| Study objectives | 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(s) | Regional Health Command-Central (RHC-C) Institutional Review Board, 29/09/2016, Protocol C.2016.202d |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 29/09/2016 |
| Completion date | 18/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 27 |
| Key inclusion criteria | Adults (Department of Defense [DoD] beneficiaries and active duty military patients aged 18-80) scheduled for urodynamic testing |
| Key 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 |
| Date of first enrolment | 01/09/2017 |
| Date of final enrolment | 30/12/2018 |
Locations
Countries of recruitment
- United States of America
Study participating centre
78234
United States of America
Sponsor information
Government
3551 Roger Brooke Dr
Fort Sam Houston
78234
United States of America
"ROR" |
https://ror.org/00m1mwc36 |
|---|
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Plan to submit for publication by June 2018. |
| IPD sharing plan | The data that is stored is de-identified from the validated questionnaires and demographic information. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 09/04/2019 | 09/04/2019 | No | No |
Additional files
- ISRCTN17581455_BasicResults_09Apr19.pdf
- Uploaded 09/04/2019
Editorial Notes
09/04/2019: The following changes were made to the trial record:
1. The total final enrolment number was added.
2. The basic results of this trial have been uploaded as an additional file.
3. The intention to publish date was changed from 01/06/2018 to 30/04/2019.
09/05/2018: Internal review.
