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临床试验/CTRI/2025/01/079076
CTRI/2025/01/079076招募中不适用

Effect of Implementation of Noise Reduction Protocols in Decibel Reduction, Quality of Sleep and Incidence of Delirium in Patients in Critical Care Settings (ICU) : A Prospective study in selected hospital of New Delhi.

Dr Ruchi Gupta1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
To determine the effectiveness of noise reduction protocols on decibel reduction in ICU

研究概览

简要总结

This study aims to evaluate the effectiveness of noise reduction protocols in reducing decibel levels, improving sleep quality, and lowering delirium incidence in ICU patients. Conducted over 7 months in the Critical care unit of Holy Family Hospital  it follows a prospective, quasi-experimental cohort design using a quantitative approach .The study involves three phases :First phase baseline data collection (3 months), Second Phase protocol implementation through staff training (1 month), and Final Phase post-intervention reassessment (3 months). Sound levels are measured at key locations and times, while sleep quality and delirium are assessed using a predefined questionnaire and CAM-ICU scores. The study aims to identify and address noise sources, enhance patient outcomes, and demonstrate the impact of noise reduction protocols in critical care settings.

Objectives

  • Primary: To assess the impact of noise reduction protocols on decibel levels in the ICU.
  • Secondary: To evaluate their effects on patient sleep quality and the incidence of delirium using the CAM-ICU score.

MethodologyThe study includes ICU patients over 18 years of age, conscious and oriented for at least 48 hours, excluding those on sedation, with neurological, psychiatric, hearing, or speech disorders, or requiring NIV for the first time.

  • Baseline Phase (3 months): Collect data on sound levels (8 times/day), sleep quality using a questionnaire, and delirium incidence through the CAM-ICU score.
  • Intervention Phase (1 month): Implement noise reduction protocols through staff education, a predefined training program and implementation of predefined noise protocol.
  • Reassessment Phase (3 months): Measure post-intervention decibel levels, sleep quality, and delirium incidence using the same tools.

Tools Used

  • Decibel meter to record sound at key ICU locations and times.
  • CAM-ICU score for delirium assessment.
  • Sleep quality questionnaire.
  • Training module for staff education.

Expected OutcomesThe study aims to identify correctable noise sources, assess protocol effectiveness in reducing noise levels, improve sleep quality, and reduce delirium incidence in ICU patients.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Age more than 18 years admitted in ICU 2.Conscious and Oriented patients for at least 48hrs during ICU stay.

排除标准

  • 1.Patient on sedation 2.Patient presenting with neurological disorder like stroke 3.Patient suffering from any psychiatric illness 4.Age less than 18 years 5.Patient with hearing and speech disorders 6.Patient requiring NIV for the first time.

结局指标

主要结局

To determine the effectiveness of noise reduction protocols on decibel reduction in ICU

时间窗: 8am,11am,2pm,5pm,8pm,11pm, 3am,6am

次要结局

  • To assess the effectiveness of noise reduction protocols on quality of sleep.(After 48 hours of conscious and oriented ICU stay)
  • To assess the incidence of delirium in patients in critical care settings (ICU)(After 48 hours of conscious and oriented ICU stay)

研究者

发起方
Dr Ruchi Gupta
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ruchi Gupta

Holy Family Hospital

研究点 (1)

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