| CTRI Number |
CTRI/2020/07/026836 [Registered on: 27/07/2020] Trial Registered Prospectively |
| Last Modified On: |
20/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of COVID - 19 pandemic researchers |
|
Scientific Title of Study
|
A study to assess the Impact of COVID -19 pandemic on the PhD scholars research activities in MAHE, Manipal |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Elsa Sanatombi Devi |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Room No 109
Department of Medical Surgical Nursing
Manipal College of Nursing
Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8310769938 |
| Fax |
|
| Email |
elsa.sana@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Elsa Sanatombi Devi |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Room No 109
Department of Medical Surgical Nursing
Manipal College of Nursing
Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8310769938 |
| Fax |
|
| Email |
elsa.sana@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Elsa Sanatombi Devi |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing |
| Address |
Room No 109
Department of Medical Surgical Nursing
Manipal College of Nursing
Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8310769938 |
| Fax |
|
| Email |
elsa.sana@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Manipal Academy of Higher Education
Madhavnagar, Manipal |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Elsa Sanatombi Devi |
Manipal College of Nursing |
Manipal College of Nursing, Manipal Academy of Higher Education, Madhavnagar, Manipal
Udupi
KARNATAKA |
08202922443
08202922443
elsa.sana@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College & Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy PhD Scholars of Manipal Academy of Higher Education |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Research Scholars willing to participate in the study
Those currently perusing PhD under Manipal Academy of Higher Education
|
|
| ExclusionCriteria |
| Details |
PhD Scholars (Researchers) outside Manipal Academy of Higher Education
PhD Scholars who do not give consent for participating in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity of the impact of COVID 19 pandemic on the researchers |
one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of Severity of Impact and the demographic details of participants |
one month |
|
|
Target Sample Size
|
Total Sample Size="1850"
Sample Size from India="1850"
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)
|
10/08/2020 |
| 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="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
The data such as Severity of impact of Covid 19 pandemic on the life of researchers will be published
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an observational study done to assess the impact of COVID-19 pandemic on the life of researchers (PhD scholars of Manipal Academy of Higher Education, Manipal).
The sample of the study is Research Scholars of Manipal Academy of Higher Education, Manipal.
A self structured questionnaire will be given to the study participants which has two sections - 1. Sociodemographic profile and 2. Questionnaire on the impact of COVID 19 pandemic on researchers
The participants will be asked to participate in the survey through emails. Google forms will be made to fill in their data on the questionnaire. Participant Information Sheet and an Informed Consent will be obtained online through the google forms from the study participants.
The data received will be analyzed by the investigators and a Focus Group Discussion with 10 - 12 participants will be conducted online through MS Teams. The participants for the Focus Group Discussion will be recruited from the institutes coming under Manipal Academy of Higher Education (MAHE). Study procedure will be obtained to the participants prior to recruitment and an informed consent will be obtained.
The results will be analyzed by the researchers.
During the whole study, the researchers ensure that the identity of the study participant will not be disclosed. |