| CTRI Number |
CTRI/2025/01/079466 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study examines how effective a computer based training program is in helping nurses to improve their knowledge of identifying and understanding heart rhythm problems at a hospital in Bengaluru. |
|
Scientific Title of Study
|
A Study To Assess The Effectiveness Of Computer Simulation Program On Knowledge Regarding Interpretation Of Cardiac Arrhythmias Among Staff Nurses From A Selected Hospitals Bengaluru |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kabilarasan M |
| Designation |
Post Graduate Student |
| Affiliation |
Narayana Hrudayalaya College of Nursing |
| Address |
room no 1
ground floor
Nursing department
Narayana Hrudayalaya College of Nursing
258/A
Bommasandra Industrial Area Anekal Taluk
Bangalore
Bangalore KARNATAKA 560099 India |
| Phone |
9742973869 |
| Fax |
|
| Email |
kabilarasan97@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Padmapriya P |
| Designation |
Professor |
| Affiliation |
Narayana Hrudayalaya College of Nursing |
| Address |
room no 1
ground floor
Nursing department
Narayana Hrudayalaya College of Nursing
258/A
Bommasandra Industrial Area Anekal Taluk
Bangalore
Bangalore KARNATAKA 560099 India |
| Phone |
8095321361 |
| Fax |
|
| Email |
padmapriya1980@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Padmapriya P |
| Designation |
Professor |
| Affiliation |
Narayana Hrudayalaya College of Nursing |
| Address |
room no 1
ground floor
Nursing department
Narayana Hrudayalaya College of Nursing
258/A
Bommasandra Industrial Area Anekal Taluk
Bangalore
Bangalore KARNATAKA 560099 India |
| Phone |
8095321361 |
| Fax |
|
| Email |
padmapriya1980@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Hrudayalaya College of Nursing
258/A
Bommasandra Industrial Area Anekal Taluk
Bangalore
Karnataka 560099
India |
|
|
Primary Sponsor
|
| Name |
Kabilarasan M |
| Address |
258/A, Bommasandra Industrial Area, Anekal Taluk, Bengaluru,pin 560099.
|
| 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 |
| Kabilarasan M |
Narayana Institute of Cardiac Science |
Room no 1
AITU devision
1 st floor
Cardiac department
Narayana health city
258/A
Bommasandra Industrial Area Anekal Taluk Bengaluru Bangalore KARNATAKA |
09742973869
kabilarasan97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academic Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Staff Nurses from a Selected Hospital |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Computer Simulation Program |
Computer Simulation Program to the Staff Nurse to enhance their Knowledge in Interpreting and Responding to Cardiac Arrhythmias
the total duration of interventions will be one hour |
| Comparator Agent |
Routine Education Program |
When the interventions will be given to the experimental group, the control group will be undergoing the routine education program in the cardiac ICU |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Staff nurses who are
1.willing to participate in a study
2.working in Narayana Hrudayalaya Institute of Cardiac Science.
3.Registered and more than 6 months of work experience in clinical
|
|
| ExclusionCriteria |
| Details |
1 Staff nurses who are not available at the time of data collection
2 staff nurses who have not registered & less than 6 months of clinical experience |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the effectiveness of computer simulation program on knowledge regarding interpretation of cardiac arrhythmias among staff nurses
|
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2.The association between the pretest knowledge score and selected baseline variables. |
6 weeks |
|
|
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)
|
28/02/2025 |
| 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="0" Months="1" Days="21" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kabilarasan97@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
An irregular heartbeat or heart rate from the usual range is referred to as an arrhythmia. It arises from a disruption in the creation of electrical impulses, electrical conduction or both. A variety of rhythms including atrial flutter, ventricular fibrillation, atrial fibrillation, ventricular tachycardia, pulseless electrical activity, AV Block, junctional rhythm, wolf Parkinson-white, bundle branch block complete heart block, pulseless ventricular tachycardia, asystole, can be caused by arrhythmias that originate in the ventricles or atrium. Ineffective blood pumping by the heart reduces oxygenation and perfusion, which lowers cardiac output to essential organs and peripheral tissues and causes the organ to malfunction or fail. In this study, the investigator will assess the effectiveness of computer simulation program on knowledge regarding interpretation of cardiac arrhythmias among staff nurses from a selected hospital, Bengaluru. The research design planned for this study is true experimental, randomized pre-test and post-test control group design. The estimated sample size of the study is 80, experimental group 40, control group 40 and the subjects will be identified according to the inclusion and exclusion criteria by using probability sampling technique. Pre-test level of knowledge is assessed by using a structured knowledge questionnaire. After assessing the knowledge, the computer simulation program is conducted for the staff nurses by using face to face teaching with small groups for experimental groups. On the 7th day post-test level of knowledge is assessed by structured knowledge questionnaire for the staff nurses both experimental and control group. |