RCT on Running Water Sound During Urodynamic
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: Auditory intervention with running water sound.
- Who it may be relevant to
- Registry conditions: Lower Urinary Tract Symptoms (LUTS). Basic parameters: 18 years — 90 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
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of Running Water Sound on Anxiety and Urodynamic Parameters: A Multi-Center Randomized Controlled Trial
Overview
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.
Interventions
- Behavioral Auditory intervention with running water sound
standardized audio via smartphone during pressure flow study
Primary outcome measures
- Maximum urinary flow rate (Qmax) measured by urodynamic pressure-flow study [Time frame: During the pressure-flow study phase of the urodynamic procedure]
Secondary outcome measures (7)
- Anxiety level before urodynamic procedure measured by Visual Analogue Scale (VAS) [Time frame: Immediately before the start of the urodynamic procedure]
- Anxiety level during pressure-flow study measured by Visual Analogue Scale (VAS) [Time frame: During the pressure-flow study phase of the urodynamic procedure]
- Anxiety level within 15 minutes after urodynamic procedure measured by Visual Analogue Scale (VAS) [Time frame: Within 15 minutes after completion of the urodynamic procedure]
- Detrusor pressure at maximum flow rate (PdetQmax) measured by urodynamic pressure-flow study [Time frame: During the pressure-flow study phase of the urodynamic procedure]
- Proportion of participants able to micturate (void) during pressure-flow study phase [Time frame: During the pressure-flow study phase of the urodynamic procedure]
- Bladder Outlet Obstruction Index (BOOI) calculated from urodynamic pressure-flow study [Time frame: At the point of maximum urinary flow rate during the pressure-flow study]
- Bladder Contractility Index (BCI) calculated from urodynamic pressure-flow study [Time frame: At the point of maximum urinary flow rate during the pressure-flow study]
Eligibility criteria
Inclusion criteria
- Chinese women aged 18-90 years scheduled for urodynamic study.
- Understand written traditional Chinese.
- Willing to participate and provide a written informed consent.
Exclusion criteria
- 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.
- Patients with hearing impairments that would prevent perception of the running water sound.
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
Hong Kong · 2 centers
- Caritas Medical Centre — Hong Kong
- Princess Margaret Hospital — Hong Kong
Publications
- Suskind AM, Clemens JQ, Kaufman SR, Stoffel JT, Oldendorf A, Malaeb BS, Jandron T, Cameron AP. Patient perceptions of physical and emotional discomfort related to urodynamic testing: a questionnaire-based study in men and women with and without neurologic conditions. Urology. 2015 Mar;85(3):547-51. doi: 10.1016/j.urology.2014.11.001. PMID 25733264
- Ozturk E, Hamidi N, Yikilmaz TN, Ozcan C, Basar H. Effect of Listening to Music on Patient Anxiety and Pain Perception during Urodynamic Study: Randomized Controlled Trial. Low Urin Tract Symptoms. 2019 Jan;11(1):39-42. doi: 10.1111/luts.12191. Epub 2017 Aug 23. PMID 28834330
- Kwon WA, Kim SH, Kim S, Joung JY, Chung J, Lee KH, Lee SJ, Seo HK. Changes in urination according to the sound of running water using a mobile phone application. PLoS One. 2015 May 15;10(5):e0126798. doi: 10.1371/journal.pone.0126798. eCollection 2015. PMID 25978378
- Culha Y, Ak ES, Culha MG. The Effect of Running Water Sound Listened to Patients During Urodynamics on Anxiety and Urodynamic Parameters. Int Neurourol J. 2023 Sep;27(3):217-223. doi: 10.5213/inj.2346116.058. Epub 2023 Sep 30. PMID 37798889
Identifiers
NCT: NCT07451548 · water sound in urodynamic