FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. 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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kabilarasan97@gmail.com].

  6. 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.

  7. 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.

 
Close