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CTRI Number  CTRI/2024/06/069609 [Registered on: 27/06/2024] Trial Registered Prospectively
Last Modified On: 26/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Communication Protocol]  
Study Design  Other 
Public Title of Study   A study to compare flexible visiting policy with specific communication protocol Vs restrictive visiting policy on incidence of delirium among patients admitted in ICUs and their caregiver satisfaction in PGIMER,Chandigarh 
Scientific Title of Study   A comparative study on flexible visiting policy with specific communication protocol Vs restrictive visiting policy on incidence of delirium among patients admitted in ICUs and their caregiver satisfaction in PGIMER Chandigarh 2023 2025 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjali Singh 
Designation  Student 
Affiliation  National Institute of Nursing Education, Post-Graduate Institute of Medical Education and Research 
Address  Room- 207 Department- Nursing National Institute of Nursing Education PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  8546089500  
Fax    
Email  anjalivishenrajput@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sukhpal Kaur 
Designation  Principal 
Affiliation  National Institute of Nursing Education, Post-Graduate Institute of Medical Education and Research 
Address  Room number- 107 Principal Office Department- Nursing National Institute of Nursing Education PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9888536964  
Fax    
Email  sukhpal.trehan@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Sukhpal Kaur 
Designation  Principal 
Affiliation  National Institute of Nursing Education, Post-Graduate Institute of Medical Education and Research 
Address  Room no- 107 Principal Office Department - Nursing National Institute of Nursing Education PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9888536964  
Fax    
Email  sukhpal.trehan@yahoo.in  
 
Source of Monetary or Material Support  
Department of Anesthesia & Intensive care and Department of Pulmonary medicine , Nehru Hospital, PGIMER, Chandigarh, India- 160012 
self funded 
 
Primary Sponsor  
Name  Anjali Singh 
Address  Room 207 National Institute of Nursing Education, PGIMER, Chandigarh, India 160012 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anjali singh  Nehru Hospital   Department of Anesthesia and Intensive care 2nd floor Room 20 and Department of Pulmonary medicine 4th floor Room 5 , PGIMER, Chandigarh
Chandigarh
CHANDIGARH 		 8546089500

anjalivishenrajput@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education & Research Chandigarh Institutional Ethics Committee (Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Caregiver of patient admitted in ICU 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Routine Care  comparing with routine care of ICU having restrictive visiting Policy after 7 days 
Intervention  specific Communication Protocol  A protocol related to specific Communication providing caregiver what to talk and do while visiting to their patient admitted in ICU having flexible visiting policy. Intervention is given on 3 consecutive days that is Day 1 2 and 3 about specific Communication Protocol and 4 observations are made on alternate days that is day 1 3 5 and 7  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  ICU stay of more than 48 hours with family member as caregiver 
 
ExclusionCriteria 
Details  Delirium at base line
APACHE II score more than 35
RASS -4 or -5 for more than 96 hours 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of delirium
Caregiver satisfaction
Nurse perspective on visiting policy 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Length of ICU stay
Nosocomial Infection
 		 3 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 2 
Date of First Enrollment (India)   08/07/2024 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

ICU patients who experience delirium, face a substantial risk of consequences, including prolonged hospital stays in the ICU, a sluggish recovery, a high death rate, and eventually an overburdening of the healthcare system .Delirium is a substantial problem in critically ill patients. Involvement of caregiver in care and allowing them for 24 hours near their patient as in  flexible visiting policy there is reduced incidence of delirium in ICU patients, without increasing the risks of nosocomial infection or mortality. But still maximum ICUs are having restrictive visiting policy. Since there are currently no noteworthy randomized trials examining the effects of flexible family visiting rules on patients, family members, and ICU staff, it may be challenging to decide how to implement ICU visiting policies most effectively. Hence the aim of this study is to explore the effect of “flexible visiting policy with specific communication protocol on incidence of delirium among patients admitted in ICUs and their caregiver satisfaction  and compare it with restrictive visiting policy of ICU.

H0 (1): There is no significant difference in the incidence of delirium among patients admitted in ICUs  with flexible visiting policy with specific communication protocol and restrictive visiting policy.

H0 (2): There is no significant difference between flexible visiting policy with specific communication protocol and restrictive visiting policy on caregiver’s satisfaction

Ha (1): Flexible visiting policy with specific communication protocol will reduce the incidence of delirium among patients admitted in ICUs.

Ha (2): Flexible visiting policy with specific communication protocol will improve caregiver’s satisfaction.

Ha (3): Flexible visiting policy with specific communication protocol will decrease in the length of ICU stay.

Ha (4): Flexible visiting policy with specific communication protocol will not increase hospital acquired infection in patients admitted in ICUs.

 
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