| CTRI Number |
CTRI/2023/10/058447 [Registered on: 09/10/2023] Trial Registered Prospectively |
| Last Modified On: |
03/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Postoperative care ] |
| Study Design |
Other |
|
Public Title of Study
|
Simulation based learning on post-operative care of CABG (coronary artery Bypass grafting)patients |
|
Scientific Title of Study
|
A study to assess the effectiveness of simulation based learning on postoperative care of CABG patients in terms of competency among nursing students of selected nursing colleges of Haryana. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sristisingh |
| Designation |
Nursing |
| Affiliation |
Maharishi Markandeshwar (Deemed to be university) Mullana, Ambala |
| Address |
Medical surgical nursing department
M.M.COLLEGE OF NURSING MULLANA, AMBALA
Ambala
HARYANA
133207
India |
| Phone |
7465931449 |
| Fax |
|
| Email |
sristisinghom@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vinay Kumari |
| Designation |
Professor |
| Affiliation |
Maharishi Markandeshwar (Deemed to be university) Mullana, Ambala |
| Address |
Medical Surgical Nursing department
M.M.COLLEGE OF NURSING MULLANA
AMBALA
Ambala
HARYANA
133207
India |
| Phone |
7973596469 |
| Fax |
|
| Email |
viceprincipalmmcn@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Sristisingh |
| Designation |
Nursing |
| Affiliation |
Maharishi Markandeshwar (Deemed to be university) Mullana, Ambala |
| Address |
Medical surgical nursing department
M.M.COLLEGE OF NURSING MULLANA, AMBALA
Ambala
HARYANA
133207
India |
| Phone |
7465931449 |
| Fax |
|
| Email |
sristisinghom@gmail.com |
|
|
Source of Monetary or Material Support
|
| m m college of nursing Mullana Ambala |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Deemed University |
| Address |
M.M.COLLEGE OF NURSING MULLANA, AMBALA |
| 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 |
| Sristi Singh |
Maharishi Markandeshwer Deemed to be university |
M.M. College of Nursing
Mullana
Ambala
HARYANA |
7465931449
sristisinghom@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of decision of the Ethics committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nursing students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no intervention given to comparison group |
no intervention given to comparison group |
| Intervention |
Simulation based learning |
simulation based learning on post operative care of CABG patient via conventional teaching and skill demonstration |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
the study will include nursing students who are:
Students of B.Sc. Nursing 2nd year
Available at the time of data collection
|
|
| ExclusionCriteria |
| Details |
the study will exclude nursing students who are:
Absent for post test or intervention.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge skill and clinical decision making ability |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| knowledge, skill & clinical decision making among nursing students |
1 month |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
13/10/2023 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A study to assess the effectiveness of
simulation based learning on postoperative care of CABG patients in terms of
competency among nursing students of selected nursing colleges of Haryana |