Does Use of a Pre-Procedure Educational Video for Urodynamic Testing Reduces Anxiety?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: video.
- Who it may be relevant to
- Registry conditions: Urinary Incontinence, Urinary Bladder Overactive, Urinary Incontinence , Stress. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of a Pre-Procedure Educational Video for Urodynamic Testing as a Tool to Reduce Anxiety: A Prospective Randomized Study
Overview
The objective of this randomized prospective study is to evaluate whether viewing an educational video before urodynamic testing reduces anxiety among women undergoing evaluation for pelvic floor or urinary symptoms. The primary research question is: Does viewing a short educational video before urodynamic testing reduce objective and subjective anxiety levels and improve the overall testing experience? Participants scheduled to undergo urodynamic testing as part of routine clinical care will be randomly assigned to either an educational video intervention or standard pre-procedure counseling alone. Participants will complete brief questionnaires, provide saliva samples for cortisol measurement as an objective biomarker of stress, and report anxiety and pain levels before, during, and after urodynamic testing.
Detailed description
his study examines whether viewing a short educational video before urodynamic testing reduces anxiety, embarrassment, and discomfort, and improves participants' understanding of the procedure. Urodynamic testing evaluates bladder and urethral sphincter function, and many women experience stress before undergoing the examination. Eligible participants are women whose treating physician has recommended urodynamic testing as part of the evaluation of urinary or pelvic floor symptoms. Participation in the study is entirely voluntary.
Following informed consent, participants will meet with a member of the research team, who will explain the purpose of the study and the urodynamic procedure. Participants will then be randomly assigned to either an educational video intervention group or a standard verbal explanation group. Before the procedure, participants will complete brief questionnaires assessing stress level, coping style, and demographic and clinical characteristics. A saliva sample will be collected for cortisol measurement as an objective biomarker of stress, and blood pressure and heart rate will be recorded.
During urodynamic testing, participants will rate anxiety and pain using a numerical rating scale from 1 to 10, and an additional saliva sample will be collected. After completion of the examination, participants will complete a brief questionnaire evaluating the overall experience, including anxiety, embarrassment, and discomfort. The total duration of study-related procedures, including urodynamic testing, is approximately one hour.
No additional medical risks are anticipated beyond those associated with standard urodynamic testing. Some participants may experience minor discomfort when answering personal questions or providing saliva samples. No additional procedural risks are expected. Although individual benefit cannot be guaranteed, participation may improve preparation for urodynamic testing and reduce anxiety or discomfort. The knowledge gained from this study may contribute to improving the care of future patients undergoing urodynamic evaluation.
All study data will be coded and maintained confidentially to protect participant privacy. Access to identifiable information will be limited to the investigators and authorized regulatory authorities, in accordance with applicable regulations. No identifying information will appear in reports or publications. Participation is voluntary, and participants may decline participation or withdraw from the study at any time without affecting current or future medical care.
Interventions
- Other video
A short video explaining the urodynamics test.
Primary outcome measures
- Anxiety represented by cortisol levels [Time frame: through study completion, an average of 1 hour]
Secondary outcome measures (1)
- Heart rate and subjective questionnaires [Time frame: through study completion, an average of 1 hour]
Eligibility criteria
Inclusion criteria
- women 18 years and above, undergoing a urodynamics test
Exclusion criteria
- women under SSRI/SNRI treatment women with a known anxiety disorder women who had a previous urodynamics test
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Israel · 1 center
- Meir Medical Center — Kfar Saba
Identifiers
NCT: NCT07740629 · 0210-20-MMC