| CTRI Number |
CTRI/2021/08/035824 [Registered on: 19/08/2021] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Electro Cardio Gram Interpretation on Knowledge and skill |
|
Scientific Title of Study
|
Effectiveness of Electro Cardio Gram Interpretation Intervention (ECGII) on knowledge and skill among nursing students at selected nursing institutions, Uttar Pradesh. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HARIPRASATH PANDURANGAN |
| Designation |
Research Schloar, Himalayan University |
| Affiliation |
Jyoti College of Management Science & technology |
| Address |
Room 45, Department of Nursing, Himalayan University Itanagar, Arunchal Pradesh. Mundia Ahmed nagar, Pilibhit Bypass road, bareilly, Uttarpradesh. Papum Pare ARUNACHAL PRADESH 791111 India |
| Phone |
8265993671 |
| Fax |
|
| Email |
hariprasath173333@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
HARIPRASATH PANDURANGAN |
| Designation |
Research Schloar, Himalayan University |
| Affiliation |
Jyoti College of Management Science & technology |
| Address |
Himalayan University Itanagar, Arunchal Pradesh. Mundia Ahmed nagar, Philibhit Bypass road, Bareilly, uttarpradesh. Lower Subansiri ARUNACHAL PRADESH 791111 India |
| Phone |
8265993671 |
| Fax |
|
| Email |
hariprasath173333@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
HARIPRASATH PANDURANGAN |
| Designation |
Research Schloar, Himalayan University |
| Affiliation |
Jyoti College of Management Science & technology |
| Address |
Himalayan University Itanagar, Arunchal Pradesh. Mundia Ahmed Nagar, pilibhit Bypass road, Bareilly, Uttarpradesh. Papum Pare ARUNACHAL PRADESH 791111 India |
| Phone |
8265993671 |
| Fax |
|
| Email |
hariprasath173333@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jyoti College of Management Sicence & Technology |
|
|
Primary Sponsor
|
| Name |
Hariprasath pandurangan |
| Address |
Research Scholar, Himalayan University, Itanagar, Arucnachal Pradesh |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Hariprasath |
Jyoti College of Management Science & Technology |
Room No 6 Mundia Ahmed Nagar, Barilley, Pilibhit Bypass road, Barilly. Bareilly UTTAR PRADESH |
8265993671
hariprasath173333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethical Committe |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ECG interpretation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional education intervention |
Duration 10 hrs and the frequency is one time. |
| Intervention |
ECG interpretation intervention (ECGII) will be administrated to experimental group for 5 days which includes 15 different sessions. Post-test one will be conducted after 21 days of pre-test using the same tool for experimental group. After post one ECGII will be administrated for 5 days with 15 different sessions for experimental group. Post-test two will be conducted 21 days after post-test one using the same tool and the same method. Similarly, post-test three will be conducted 21 days after post-test two using the same tool and the same method. |
Duration of the intervention is 5 days and the frequency of the intervention is 3 times. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Nursing students who were studying GNM II year, GNM III-year, BSc II year, BSc III year, BSc IV year, P. BSc I year and P. BSc II year
• Both female and male nursing students. |
|
| ExclusionCriteria |
| Details |
Nursing students who were on leave during the data collection period. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase knowledge and skill among nursing students |
Base line, 21 days, 42 days, 63 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The ECGII will assist nursing students in gaining extensive knowledge and expertise in ECG interpretation. As a result, when they work in critical care units, it will be beneficial for them. This ECGII will reduce disability and death from
128
Cardiac emergencies by enhancing nursing students knowledge and skill on ECG interpretation and will strengthen health care system. |
2 Years |
|
|
Target Sample Size
|
Total Sample Size="400" Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="400" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/08/2021 |
| Date of Study Completion (India) |
31/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Pandurangan, H., Raja, A., & Balasubramanian, N. (2020). A cross-sectional survey to assess the level of skill on ECG and its interpretation among nursing students. IDC Int J, 7(4), 61-66.
10.
Pandurangan, H., Raja, A., & Balasubramanian, N. (2020). A cross sectional survey to assess the level of knowledge on ECG and its interpretation among nursing students. The Genesis, 7(4), 72-76.Pandurangan, H., Balasubramanian, N., Raja, A., & Malhotra, R. (2022). Effectiveness of Electrocardiogram Interpretation Intervention (ECGII) on Knowledge and Skill Among Nursing Students. ECS Transactions, 107(1), 6067. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
An evaluate study was conducted to find out the effectiveness of ECG interpretation intervention (ECGII) on knowledge and skill among nursing students. A true experimental research design with pre- and post-test control group design was used in this study. Nursing students in their GNM II year, GNM III year, BSc II year, BSc III year, BSc IV year, P. BSc I year, and P. BSc II year in selected nursing institutions Bareilly and who met the inclusion criteria were included in the study. The samples were selected using simple random sampling technique with computer-generated Haahr’s random number table, a total of 200 samples for each experimental and control group had chosen. Data was collected using pretested, validated and reliable tool which includes self-administrated structured knowledge questionnaire and case vignette tool on ECG and its interpretation. The researcher developed ECG Interpretation Intervention (ECGII) on Knowledge and skill among nursing students. For experimental group pre-test was conducted and then ECGII was administrated for 5 days with 15 different sessions. Post- test one, post-test two, post-test three were conducted in similar manner with 21 days apart between the post-tests. Likewise, for control group same the method has been repeated without administration of ECGII. |