Interventions to Decrease Anxiety in Patients Undergoing Urodynamic Testing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 98
- Locations
- 4
- Primary Endpoint
- Anxiety
Study Overview
Brief Summary
This is a randomized controlled trial to determine if music, a video, or standard of care will decrease anxiety in patients undergoing urodynamic testing.
Detailed Description
Research Design and Methods
This study was a randomized controlled trial assessing the interventions of music, a patient educational video, or usual care pre-test teaching practice and anxiety before patients undergo urodynamic testing. This study enrolled women who were scheduled to undergo urodynamic testing within the Female Pelvic Medicine and Reconstructive Surgery clinic on main campus and at Fairview Hospital. Consenting participants were randomized to receive either usual practice pre-test teaching, usual practice pre-test teaching with soothing music in the background and throughout the test, or usual practice pre-test teaching and watching an educational video before the test was performed. The participants filled out a short questionnaire before urodynamic testing was started with two VAS scales assessing anxiety and pain and Likert Scale Questions, a second short questionnaire when the patient feels "strong urge" with two VAS scales assessing anxiety and pain, and a third questionnaire once the patient has completed the test again testing VAS anxiety and pain as well as some Likert scale questions.
The primary outcome was to determine if pre-urodynamic testing anxiety was decreased after watching a pre-test educational video, or by listening to music before and throughout the procedure, or by receiving standard of care pre-test teaching. Secondary outcomes were to determine baseline anxiety in our urodynamic patient population and to determine if there is decreased discomfort due to the intervention as well as to evaluate if there were certain patients that would benefit from increased information.
Enrollment All patients undergoing urodynamic testing for the first time who are over the age of 18 years old, female with presentation for urodynamics for urinary dysfunction, urinary incontinence, prolapse, or presurgical evaluation of voiding function were screened for participation in the study.
Exclusion criteria included:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 years old and above,
- •urinary dysfunction
- •urinary incontinence
- •presurgical evaluation of voiding function
- •Never undergone Urodynamics before
Exclusion Criteria
- •Pregnancy
- •Ongoing urinary tract infections
- •Inability to cooperate
- •Inability to give consent
- •Non-English speakers
- •Patients who have undergone urodynamic testing in the past
Outcomes
Primary Outcomes
Anxiety
Time Frame: One day
The primary outcome is to determine if pre-urodynamic testing anxiety is decreased after watching a pre-test educational video, or by listening to music before and throughout the procedure, or by receiving standard of care pre-test teaching. For measurement of anxiety we used 100mm Visual analog scales. We used a questionnaire to obtain demographics. We used a five point Likert scale to ask questions about their use of the internet and information seeking behavior.
Secondary Outcomes
- Discomfort(One Day)