Does Use of a Pre-Procedure Educational Video for Urodynamic Testing Reduces Anxiety?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorYair Daykan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
women 18 years and above, undergoing a urodynamics test
Disqualifiers
women under SSRI/SNRI treatment women with a known anxiety disorder women who had a previous urodynamics test
Trial design
Design model
Parallel
Treatments tested in this trial
video
Other interventionA short video explaining the urodynamics test.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Study group- videoExperimental treatment 1 intervention
Group B: Control group- No videoNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Anxiety represented by cortisol levels
Comparison between levels of salivary cortisol concentrations before and at the end of the urodynamics test, between the two groups. Cortisol level in nmol/L . the higher difference show increase in stress level
Time frame
through study completion, an average of 1 hourSecondary outcomes
1
Heart rate and subjective questionnaires
Comparison between levels of heart rate and subjective anxiety level questionnaire scores, before and during the urodynamics test, between the two groups.
Time frame
through study completion, an average of 1 hourSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yair Daykan
Lead sponsor
Meir Medical Center
Sponsor institution
Source ClinicalTrials.gov