Stress Incontinence, FemaleNCT03625843
Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing
A study testing Mindfulness exercises in people with Stress Incontinence, Female and Overactive Bladder, run by San Antonio Uniformed Services Health Education Consortium.
Trial summary
In this pilot study the investigators attempt to answer the question, does mindfulness exercises before urodynamic testing reduce patient's perception of anxiety or pain? Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Incontinence, Female, Overactive Bladder, Lower Urinary Tract Symptoms
- What is being tested?
- Mindfulness exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 29 Sep 2016to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of urinary symptoms requiring urodynamic testing
- Stress incontinence
- Mixed incontinence
- Urge incontinence
- Overactive bladder
- Urinary retention
- Lower urinary tract symptoms
- Are Department of Defense (DoD) beneficiaries
Who cannot join
- Neurogenic bladder
- Interstitial cystitis
- Chronic bladder pain
- Inability to have urodynamics performed
- Are Not DoD beneficiaries
- Pregnant
- Lack capacity to consent
About this study
Official title: Incorporation of Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing: a Randomized Controlled Trial
In this pilot study the investigators attempt to answer the question, does mindfulness exercises before urodynamic testing reduce patient's perception of anxiety or pain?
Read the detailed description
The subjects are being asked to consider participation in this research study. The purpose of this study is to see if incorporating mindfulness exercises prior to urodynamic studies (UDS) results in less pain, anxiety and discomfort.
The participants will be guided through a mindfulness meditation exercise by a licensed professional. During this exercise participants will be asked to focus attention on 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 participants will be randomly assigned to one of 2 treatment plans. Randomization is a process like flipping a coin and means the chance of being assigned to either of the plans. One treatment plan includes undergoing mindfulness exercises prior to your UDS evaluation. The other treatment plan includes simply undergoing the UDS evaluation.
After the participants UDS evaluation, questions will be asked about the urodynamic procedure. The participants will be asked to answer questions on a UDS and anxiety questionnaire which pertain to emotional and physical experiences during the procedure.
- Being tested
- Mindfulness exercises
- Keywords
- urodynamics
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Bladder, Overactive, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness exercisesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mindfullness exercises | Experimental | Participate in mindfulness exercises prior to urodynamic studies (UDS). As a participant, you will be guided through a mindfulness meditation exercise by a licensed professional. During this exercise you will be asked to focus your attention on your breathing, physical sensations, and thoughts. This exercise will last for approximately 10 minutes. Receives: Behavioral: Mindfulness exercises |
| Control | No intervention | Sitting quietly in a room alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety during urodynamics as measured the STAI-6.
The STAI-6, State Trait Anxiety Inventory, is a validated questionnaire that measures anxiety. The total score from the STAI-6 will be used with a range of score from 4-24. Higher scores indicate higher level of anxiety.
Measured: Day 1
Secondary outcomes (2)
Positive and negative emotions as measured by the urodynamic questionnaire
The urodynamic questionnaire is clinically validated with participants self-reporting emotions fear, discomfort, embarrassment, and if the test was better or worse than expected. The questions are analyzed individually with score ranked on a likert scale of 1-4. Higher score indicate higher levels of that particular emotion.
Measured: Day 1
Pain as measured by the VAS
The visual analog scale (VAS) for pain total score will be recorded. The minimum and Maximum scores range from 1-10. Higher scores indicate more pain.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start29 Sep 2016
- Primary completion30 Dec 2017
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Incontinence, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Antonio Uniformed Services Health Education Consortium
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Forrest Jellison, San Antonio Uniformed Services Health Education Consortium
- Investigators
- Forrest C Jellison, MD, Principal investigator, San Antonio Uniformed Services Health Education Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625843
- Sponsor's protocol ID
- c.2016.202d
- Status last verified
- Aug 2018
- First submitted
- 25 Jul 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporation of Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03625843
- Acronym / sponsor ID
- c.2016.202d
- Keywords
- urodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- San Antonio Uniformed Services Health Education ConsortiumUS federal agency
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this pilot study the investigators attempt to answer the question, does mindfulness exercises before urodynamic testing reduce patient's perception of anxiety or pain?
Detailed description
The subjects are being asked to consider participation in this research study. The purpose of this study is to see if incorporating mindfulness exercises prior to urodynamic studies (UDS) results in less pain, anxiety and discomfort.
The participants will be guided through a mindfulness meditation exercise by a licensed professional. During this exercise participants will be asked to focus attention on 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 participants will be randomly assigned to one of 2 treatment plans. Randomization is a process like flipping a coin and means the chance of being assigned to either of the plans. One treatment plan includes undergoing mindfulness exercises prior to your UDS evaluation. The other treatment plan includes simply undergoing the UDS evaluation.
After the participants UDS evaluation, questions will be asked about the urodynamic procedure. The participants will be asked to answer questions on a UDS and anxiety questionnaire which pertain to emotional and physical experiences during the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfullness exercises | Experimental | Behavioral: Mindfulness exercisesParticipate in mindfulness exercises prior to urodynamic studies (UDS). As a participant, you will be guided through a mindfulness meditation exercise by a licensed professional. During this exercise you will be asked to focus your attention on your breathing, physical sensations, and thoughts. This exercise will last for approximately 10 minutes. |
| Control | No intervention | –Sitting quietly in a room alone. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of urinary symptoms requiring urodynamic testing
- Are Department of Defense (DoD) beneficiaries
Key exclusion criteria (7 listed)
- Neurogenic bladder
- Interstitial cystitis
- Chronic bladder pain
- Inability to have urodynamics performed
- Are Not DoD beneficiaries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness exercises | Behavioural | Mindfullness exercises |
Primary outcome
Anxiety during urodynamics as measured the STAI-6.
Time frame: Day 1
The STAI-6, State Trait Anxiety Inventory, is a validated questionnaire that measures anxiety. The total score from the STAI-6 will be used with a range of score from 4-24. Higher scores indicate higher level of anxiety.
2 secondary outcomes
Positive and negative emotions as measured by the urodynamic questionnaire
Time frame: Day 1
Pain as measured by the VAS
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Forrest C Jellison, MD principal investigator
San Antonio Uniformed Services Health Education Consortium
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness exercises in people with Stress Incontinence, Female and Overactive Bladder, run by San Antonio Uniformed Services Health Education Consortium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety during urodynamics as measured the STAI-6. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.