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CTRI Number  CTRI/2025/01/079076 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Other 
Public Title of Study   This study investigates whether reducing the noise in ICU helps patients sleep better, reduces noise levels, and lowers the chances of confusion or delirium. 
Scientific Title of Study   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. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ruchi Gupta 
Designation  Consultant 
Affiliation  Holy Family Hospital 
Address  Department of Critical Care Medicine Holy Family Hospital Okhla Road New Delhi

South
DELHI
110025
India 
Phone  9910695602  
Fax    
Email  ruchi_gupta.mamc@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Arshdeep S Chadha 
Designation  Consultant 
Affiliation  Holy Family Hospital 
Address  Department of Critical Care Medicine Holy Family Hospital Okhla Road New Delhi

South
DELHI
110025
India 
Phone  9810802349  
Fax    
Email  arsh112in@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sumit Ray 
Designation  Medical Director & Head of the Department 
Affiliation  Holy Family Hospital 
Address  Department of Critical Care Medicine Holy Family Hospital Okhla Road New Delhi

South
DELHI
110025
India 
Phone  9810614433  
Fax    
Email  drsray67@yahoo.co.in  
 
Source of Monetary or Material Support  
Holy Family Hospital Okhla Road New Delhi-110025 India 
 
Primary Sponsor  
Name  Dr Ruchi Gupta 
Address  Department of Critical Care Medicine Holy Family Hospital Okhla Road New Delhi-110025 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ruchi Gupta  Holy Family Hospital  Department of Critical Care Medicine Holy Family Hospital Okhla Road New Delhi-110025 India
South
DELHI 		 9910695602

ruchi_gupta.mamc@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Holy Family Hospital Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Y33||Other specified events, undetermined intent,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Decibel in ICU   In the first (1st 3 months) and third phase (Last 3 months), Decibel Meter is used to determine the effectiveness of noise reduction protocols on decibel reduction in ICU. Sound decibel will be recorded at: 8am,11am, 2pm, 5 pm, 8pm, 11pm, ,3am, 6am.The data will be assessed pretraining (For 3 months) and post training (for 3 months).  
Comparator Agent  Delirium CAM ICU score  Incidence of delirium will be calculated by CAM ICU score in critical care settings (ICU). The data will be assessed pretraining (For 3 months) and post training (for 3 months). 
Intervention  Noise reduction protocol   Predefined protocol targeting reduction of noise in ICU will be implemented over a period of a month including silencing of phone, appropriate alarm limit and volumes for all patients, Quiet Time (3-5pm and 1-4pm) identification of instruments causing noise and appropriate maintenance if warranted, appropriate signage to keep silence, etc.  
Comparator Agent  Patient sleep quality   Patient sleep will be assessed by predefined questionnaire for sleep quality, to assess the effectiveness of noise reduction protocols on Quality of sleep. The data will be assessed pretraining (For 3 months) and post training (for 3 months).  
Intervention  Predefined training program for staff education and sensitization  The second phase, lasting one month, involves implementing the intervention through staff education and sensitization via a predefined training program on effects on noise on patient and staff well being and methods to decrease noise in ICU. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Age more than 18 years admitted in ICU
2.Conscious and Oriented patients for at least 48hrs during ICU stay.  
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the effectiveness of noise reduction protocols on decibel reduction in ICU   8am,11am,2pm,5pm,8pm,11pm, 3am,6am  
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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.

Methodology

The 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 Outcomes

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

 
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