| CTRI Number |
CTRI/2022/08/045024 [Registered on: 29/08/2022] Trial Registered Prospectively |
| Last Modified On: |
26/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Simulation based learning] |
| Study Design |
Other |
|
Public Title of Study
|
To assess the effectiveness of simulation based learning among nursing students regarding management of post covid complications |
|
Scientific Title of Study
|
A study to assess the effectiveness of simulation based learning regarding management of post covid complications in terms of knowledge, clinical decision making ability and self-efficacy among Nursing Students studying in selected colleges of Ambala, 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 |
Malvika Thakur |
| Designation |
Student |
| Affiliation |
UGC (University Grant Commission) |
| Address |
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University) Mullana ambala (Haryana).
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University) Mullana ambala (Haryana).
Ambala
HARYANA
133207
India |
| Phone |
8580493471 |
| Fax |
01731-274375 |
| Email |
rajputmalvi4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Eenu |
| Designation |
Masters in Community Health Nursing |
| Affiliation |
UGC (University Grant Commission) |
| Address |
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University) Mullana ambala (Haryana).
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University) Mullana ambala (Haryana).
Ambala
HARYANA
133207
India |
| Phone |
9888302633 |
| Fax |
01731-274375 |
| Email |
eenu.angel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Malvika Thakur |
| Designation |
Student |
| Affiliation |
Maharishi markandehswar deemed to be university mullana ambala |
| Address |
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University) Mullana ambala (Haryana).
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University) Mullana ambala (Haryana).
Ambala
HARYANA
133207
India |
| Phone |
8580493471 |
| Fax |
01731-274375 |
| Email |
rajputmalvi4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi markandeshwar deemed to be university |
|
|
Primary Sponsor
|
| Name |
Malvika Thakur |
| Address |
Hostel No. 7 MMU Mullana Ambala PIn code- 133207 |
| 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 |
| Malvika Thakur |
M.M.College of Nursing |
Maharishi Markandeshwar College of Nursing, Maharishi Markandeshwar (Deemed to be University) Mullana ambala (Haryana)
Ambala
HARYANA |
8580493471
01731-274375
rajputmalvi4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi Markandeshwar Institute of medical science and research mullana, ambala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparison group |
Conventional learning |
| Intervention |
Simulation based learning program regarding management of post covid complications |
Simulation based learning regarding management of post covid complications in terms of knowledge, clinical decision making ability and self-efficacy was conducted in duration of one month |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
available at the time of data collection
willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
absent at the time of intervention (simulation based learning) and at the time of Post-test. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| simulation based learning is effective to enhance knowledge, clinical decision making ability and self-efficacy of nursing students |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| self covid history, any family member affected with covid-19, have ever nursed a post COVID patient in OPD, Cumulative sessional scores, clinical evaluation marks in B.Sc. N. 2nd year |
3 weeks |
|
|
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)
|
01/09/2022 |
| 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="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A quasi experimental study conducted to assess the effectiveness of simulation based learning regarding management of post covid complications among B.Sc. nursing students of M.M. College of nursing mullana ambala that were choosen by simple random table and by using purposive sampling technique. Intervention given to experimental group only and then check the effectiveness of simulation learning among experimental group through knowledge questionnaire, clinical desicion making ability questionnaire and objective structured clinical examination for self-efficacy. |