| CTRI Number |
CTRI/2024/05/068141 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Competency based ECG training] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A trial to check effectiveness of ECG training on knowledge and correct recognition of heart attack in patients with chest pain by nurses working in emergency at AIIMS Delhi. |
|
Scientific Title of Study
|
A STUDY TO ASSESS THE EFFECTIVENESS OF COMPETENCY BASED ECG TRAINING ON KNOWLEDGE AND DIAGNOSTIC ACCURACY OF EMERGENCY NURSES IN IDENTIFYING ST SEGMENT ELEVATION MYOCARDIAL INFARCTION AMONG PATIENTS PRSENTING WITH CHEST PAIN AT AIIMS 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 |
PRATIBHA |
| Designation |
MSc student |
| Affiliation |
AIIMS Delhi |
| Address |
Room no.- Porta Cabin 2
Department-College of Nursing
AIIMS Delhi Ansari Nagar New Delhi 110029
South
DELHI
110029
India |
| Phone |
9255127848 |
| Fax |
|
| Email |
psheyoran2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Das |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Delhi |
| Address |
Room no.-Porta Cabin 2
Department - College of Nursing AIIMS Delhi Ansari Nagar New Delhi 110029
South
DELHI
110029
India |
| Phone |
9871755975 |
| Fax |
|
| Email |
smitadas307@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRATIBHA |
| Designation |
MSc student |
| Affiliation |
AIIMS Delhi |
| Address |
Room no. - Porta Cabin 2
Department- College of Nursing AIIMS Delhi Ansari Nagar New Delhi 110029
South
DELHI
110029
India |
| Phone |
9255127848 |
| Fax |
|
| Email |
psheyoran2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029. |
|
|
Primary Sponsor
|
| Name |
AIIMS Delhi |
| Address |
AIIMS Delhi Ansari Nagar New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Sanjeev Bhoi |
AIIMS NEW DELHI |
Emergency Medicine 1 Emergency Department AIIMS Delhi 110029
South
DELHI |
8527050391
sanjeevbhoi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committe For Post Graduate Research AIIMS NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nurses working in emergency department. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Competency Based ECG training |
On first day of recruitment of participants ,after obtaining informed consent, pre-test clinicodemographic sheet ,knowledge questionnaire on ECG and observation checklist to diagnose various ECG with help of case vignettes will be taken .Then researcher will start intervention which is session of one time 3 hour covering theoretical basics of Electrocardiogram ,ST segment elevation myocardial infarction with help of powerpoint presentation and Hands-on ECG will be solved among participants and researcher. Each session will provide training for maximum 6-8 participants. Such session will be continued till sample size is completed. Handout of presentation material content will be provided to participants after end of 3 hour session. A WhatsApp group will be created among participants and researcher in which participants will upload ECG pics obtained from chest pain patients coming to emergency department daily from 2nd day till 7th day. Researcher and participants will have brain storming to find correct interpretation of various ECG .Participants will be observed in clinical setting for practice of solving ECG during this period.On end of 7th day participants will solve ECG of chest pain patient at triage and competency will be assessed by researcher with help of checklist. |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Emergency nurses directly involved in patient care during data collection period.
Nurses willing to participate in study |
|
| ExclusionCriteria |
| Details |
The nurses who are on leave due to any reason
The nurses who are not involved with direct patient care |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge and Diagnostic accuracy of Emergency nurses in identifying STEMI. |
T1: pretest, at the time of enrollment
T2: posttest, after 7 days of t1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Door To Intervention time among chest pain patients |
T1: pretest, at the time of enrollment
T2: posttest, after 7 days of t1 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/08/2024 |
| 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="5"
Days="15" |
|
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 study is a quasi-experimental study with total enumerative sampling to assess effectiveness of competency based ECG training on knowledge and diagnostic accuracy of emergency nurses in identifying ST segment elevation myocardial infarction (STEMI) among patient coming with chest pain at AIIMS Delhi. Primary outcome is knowledge and diagnostic accuracy of nurses and secondary outcome is door to intervention time. There will be one session of training followed by one week follow-up through whats’app group and post test data will be collected. |