| CTRI Number |
CTRI/2025/05/087466 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Simulation Based Training] |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Effectiveness of Simulation based Training on knowledge and clinical skills of nursing officers in respiratory care of patients admitted with Acute Respiratory Distress Syndrome in ICU, AIIMS New Delhi |
Scientific Title of Study
Modification(s)
|
A study to assess the effectiveness of Simulation Based Training on knowledge and clinical skills of nursing officers in respiratory care o patients admitted with Acute Respiratory Distress Syndrome in ICU, AIIMS 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 |
Devisree A S |
| Designation |
MSC Nursing student |
| Affiliation |
AIIMS, Newdelhi |
| Address |
College of Nursing, pota cabin, AIIMS New Delhi
South West
DELHI
110064
India |
| Phone |
9633378409 |
| Fax |
|
| Email |
devisreeas5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sibi Riju |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New delhi |
| Address |
Ground floor Room no 5
College of Nursing
All India Institute Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9958879808 |
| Fax |
|
| Email |
sibiriju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sibi Riju |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New delhi |
| Address |
Ground floor Room no 5
College of Nursing
All India Institute Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9958879808 |
| Fax |
|
| Email |
sibiriju@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS New Delhi,India 110029 |
|
|
Primary Sponsor
|
| Name |
Devisree A S |
| Address |
College of Nursing,ALL India Institute of Medical Sciences Ansari nagar,New Delhi 110029 India |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Devisree AS |
AIIMS New Delhi |
AB8 ICU, 8th floor,All India Institute of Medical Sciences, New Delhi,110029
South
DELHI |
9633378409
devisreeas5@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Nursing Officers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Simulation Based Training |
Simulation Based Training on knowledge and clinical skills of Nursing officers in respiratory care of patients with ARDS admitted in ICU,AIIMS. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Nursing officers who have <5 years in AB8 ICU
Nursing Officers who are willing to study |
|
| ExclusionCriteria |
| Details |
Nursing Officers who are not present at the time of study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Knowledge of Nursing officers in respiratory care of patients admitted with Acute Respiratory Distress Syndrome in ICU |
Immediately after the study and 2 weeks after the study |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Clinical skills of Nursing officers in respiratory care of patients admitted with Acute Respiratory Distress Syndrome in ICU |
Immediately after the study & 2 weeks after the study |
|
Target Sample Size
Modification(s)
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
30/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
A quasi experimental one group pre-test posttest study based on the topic " A study to assess the effectiveness of simulation-based training on knowledge and clinical skills of Nursing officers in respiratory care of ARDS patients admitted in ICU". The study sample was conducted among Nursing officers working in AB8 ICU <5 years and who are willing to participate in study. The Nursing officers who are not present at the time of study excluded. The sample size was 35 and the convenient sampling technique was used for recruitment of participants. Participant information sheet was given and informed consent was taken. Demographic data collected. Pretest of knowledge assessed with knowledge assessment questionnaire and clinical skills with self-reported observational checklist. Interactive lecture about ARDS was given with powerpoint slides which was followed by scenario-based simulation training on respiratory care of ARDS patients. post-test of knowledge was assessed with knowledge assessment questionnaire and clinical skills was assessed with self-reported observational checklist immediately after the study and 2 weeks after the study. Statistical analysis was done. |