| CTRI Number |
CTRI/2025/07/091004 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Other (Specify) [A quality improvement project using PDSA cycle] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A quality improvement project to reduce the incidence of delirium using delirium recognition and delirium prevention protocol by critical care nurses among adult inpatients of a Critical Care Unit |
|
Scientific Title of Study
|
A quality improvement project to reduce the incidence of delirium using delirium recognition and delirium prevention protocol by critical care nurses among adult inpatients of a Critical Care Unit in a tertiary care hospital India |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Moirangthem Sonia |
| Designation |
Nursing Tutor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no133 College of Nursing AIIMS Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8741823342 |
| Fax |
|
| Email |
msonia1985@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sukhpal Kaur |
| Designation |
Principal |
| Affiliation |
NINE PGIMER Chandigarh |
| Address |
Room number 1 National Institute of Nursing Education Department of Education division 1 PGIMER Sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888536964 |
| Fax |
|
| Email |
sukhpal.trehan@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Nikhil Kothari |
| Designation |
Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room number 1 Department of anesthesiology and critical care division 2 Medical college AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996948 |
| Fax |
|
| Email |
drnikhilkothari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medipulse hospital room number 5 Basni opposite AIIMS Jodhpur 342005 Rajasthan India |
|
|
Primary Sponsor
|
| Name |
Moirangthem Sonia |
| Address |
Room number 5 Department of medical surgical nursing division 2 AIIMS Jodhpur 342005 Rajasthan India |
| Type of Sponsor |
Other [myself] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| moirangthem sonia |
Medipulse hospital |
Room number 5 department of critical care division first floor 2 basni phase II Opposite AIIMS Campus Jodhpur342005
Jodhpur
RAJASTHAN |
8741823342
msonia1985@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medipulse Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
delirium |
| Patients |
(1) ICD-10 Condition: F05||Delirium due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Delirium recognition and Delirium prevention protocol |
non pharmacological delirium recognition and prevention protocol education training will be given to critical care nurses for 40 minutes which consist of
1 Delirium recognition protocol by using CAM-ICU score chart for recognition
2 Delirium prevention protocol consist of
Multicomponent interventions
early mobility
family interventions
Sleep promotion
environmental interventions. |
| Comparator Agent |
No interventions |
No interventions will be given to the patient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult inpatients who are more or equal to 18 years of age and having RASS score of minus 2 to plus4 who will be admitted in ICU at Medipulse hospital Jodhpur
ICU Nurses who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
ICU Nurses who are on long leave during the study or are too sick at the time of data collection
Patients with a RASS score of minus 3 minus to minus 5
Patient with an implementation of interventions or protocol is contraindicated
Medical and Nursing students are excluded from the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence of delirium |
continuous from day one |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adherence to the delirium recognition and delirium prevention protocol |
next day after intervention |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
27/07/2025 |
| 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="1"
Months="0"
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
|
This Ph.D. research project aims to reduce the incidence of delirium among adult ICU inpatients through the development and implementation of an evidence-based delirium recognition and prevention protocol by critical care nurses in a tertiary care hospital in India. Using a quantitative approach and the Plan Do Study Act quality improvement model, the study will assess current practices, barriers, and facilitators, and then introduce interventions such as CAM ICU-based screening, cognitive orientation, early mobilization, family involvement, and sleep promotion. Data will be collected in three phases including baseline assessment, protocol development, and protocol implementation across multiple PDSA cycles. Outcome measures include changes in delirium incidence and adherence to protocol, supported by both quantitative and qualitative data analysis. The study expects to improve the quality of care and reduce delirium rates by 50 percent from baseline through active participation and sensitization of ICU nurses. |