RCT on Running Water Sound During Urodynamic
ConditionLower Urinary Tract Symptoms (LUTS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorPrincess Margaret Hospital, Hong Kong
About this trial
This study aims to see if listening to recorded running water sounds during a bladder function test (urodynamic study) helps patients feel calmer and makes it easier for them to empty their bladder during the test. Bladder tests can cause anxiety or discomfort, which sometimes affects results. Playing running water sounds may help patients relax and improve their experience, based on earlier research. Participants will be randomly placed into one of two groups. One group will listens to running water sounds during the test while the other group will have the test done in the usual way without additional auditory intervention. Participants rate their anxiety before, during, and after the test using simple scales. Parameters of the test will be recorded for analysis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chinese women aged 18-90 years scheduled for urodynamic study.
Understand written traditional Chinese.
Willing to participate and provide a written informed consent.
Disqualifiers
Patients who refuse to participate or provide written consent.
Patients who do not understand or comprehend written traditional Chinese.
Patients with severe cognitive impairment or inability to complete the VAS.
Patients with known psychiatric conditions that may confound anxiety measurements.
Trial design
Design model
Parallel
Treatments tested in this trial
Auditory intervention with running water sound
Behavioralstandardized audio via smartphone during pressure flow study
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Water soundExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Maximum urinary flow rate (Qmax) measured by urodynamic pressure-flow study
Maximum urinary flow rate (Qmax), defined as the peak flow rate during voluntary voiding with an indwelling catheter in place, measured in milliliters per second (mL/s) using standard urodynamic equipment. This parameter reflects bladder outlet function and is recorded automatically by the urodynamic system.
Time frame
During the pressure-flow study phase of the urodynamic procedureSecondary outcomes
1
Anxiety level before urodynamic procedure measured by Visual Analogue Scale (VAS)
Anxiety level assessed using the Visual Analogue Scale (VAS), a 10-cm horizontal line where 0 = no anxiety and 10 = extreme anxiety (higher scores indicate worse anxiety). Participants mark their current anxiety level immediately before the urodynamic procedure begins.
Time frame
Immediately before the start of the urodynamic procedure2
Anxiety level during pressure-flow study measured by Visual Analogue Scale (VAS)
Anxiety level assessed using the Visual Analogue Scale (VAS), a 10-cm horizontal line where 0 = no anxiety and 10 = extreme anxiety (higher scores indicate worse anxiety). Participants mark their anxiety level during the pressure-flow study phase of the urodynamic procedure (while listening to running water sound or in the control condition).
Time frame
During the pressure-flow study phase of the urodynamic procedure3
Anxiety level within 15 minutes after urodynamic procedure measured by Visual Analogue Scale (VAS)
Anxiety level assessed using the Visual Analogue Scale (VAS), a 10-cm horizontal line where 0 = no anxiety and 10 = extreme anxiety (higher scores indicate worse anxiety). Participants mark their current anxiety level within 15 minutes after completion of the urodynamic procedure.
Time frame
Within 15 minutes after completion of the urodynamic procedure4
Detrusor pressure at maximum flow rate (PdetQmax) measured by urodynamic pressure-flow study
Detrusor pressure at maximum flow rate (PdetQmax), defined as the detrusor pressure (in cmH₂O) recorded at the point of maximum urinary flow rate during voluntary voiding with an indwelling catheter in place. This is measured using simultaneous intravesical and intra-abdominal pressure transducers in the standard urodynamic pressure-flow study, and it reflects detrusor contractility and outlet resistance.
Time frame
During the pressure-flow study phase of the urodynamic procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Princess Margaret Hospital, Hong Kong
Lead sponsor
Caritas Medical Centre, Hong Kong
Collaborator
Source ClinicalTrials.gov