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Идёт набор NCT07451548

RCT on Running Water Sound During Urodynamic

Без фазы С лечением Lower Urinary Tract Symptoms (LUTS)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Auditory intervention with running water sound.
Кому может быть актуально
Состояния в реестре: Lower Urinary Tract Symptoms (LUTS). Базовые параметры: 18 лет — 90 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Impact of Running Water Sound on Anxiety and Urodynamic Parameters: A Multi-Center Randomized Controlled Trial

Обзор

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.

Вмешательства

  • Поведенческое Auditory intervention with running water sound
    standardized audio via smartphone during pressure flow study

Первичные конечные точки

  • Maximum urinary flow rate (Qmax) measured by urodynamic pressure-flow study [Срок оценки: During the pressure-flow study phase of the urodynamic procedure]
Вторичные конечные точки (7)
  • Anxiety level before urodynamic procedure measured by Visual Analogue Scale (VAS) [Срок оценки: Immediately before the start of the urodynamic procedure]
  • Anxiety level during pressure-flow study measured by Visual Analogue Scale (VAS) [Срок оценки: During the pressure-flow study phase of the urodynamic procedure]
  • Anxiety level within 15 minutes after urodynamic procedure measured by Visual Analogue Scale (VAS) [Срок оценки: Within 15 minutes after completion of the urodynamic procedure]
  • Detrusor pressure at maximum flow rate (PdetQmax) measured by urodynamic pressure-flow study [Срок оценки: During the pressure-flow study phase of the urodynamic procedure]
  • Proportion of participants able to micturate (void) during pressure-flow study phase [Срок оценки: During the pressure-flow study phase of the urodynamic procedure]
  • Bladder Outlet Obstruction Index (BOOI) calculated from urodynamic pressure-flow study [Срок оценки: At the point of maximum urinary flow rate during the pressure-flow study]
  • Bladder Contractility Index (BCI) calculated from urodynamic pressure-flow study [Срок оценки: At the point of maximum urinary flow rate during the pressure-flow study]

Критерии участия

Критерии включения

  • Chinese women aged 18-90 years scheduled for urodynamic study.
  • Understand written traditional Chinese.
  • Willing to participate and provide a written informed consent.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Гонконг · 2 центра
  • Caritas Medical Centre — Гонконг
  • Princess Margaret Hospital — Гонконг

Публикации

  • 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

Идентификаторы

NCT: NCT07451548 · water sound in urodynamic

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗