| CTRI Number |
CTRI/2020/10/028373 [Registered on: 13/10/2020] Trial Registered Prospectively |
| Last Modified On: |
12/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Non experimental - Qualitative |
| Study Design |
Other |
|
Public Title of Study
|
"Experiences among nurses caring patients with COVID 19" |
|
Scientific Title of Study
|
Experiences among nurses caring patients with COVID 19: A thematic analysis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Leena Sequira |
| Designation |
Principal |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Manipal School of Nursing, MCON,Manipal Academy of Higher Education
Shankerpura post.
Udupi Taluk and district.
574115
Udupi
KARNATAKA
576104
India |
| Phone |
9481971214 |
| Fax |
|
| Email |
leena.sequ@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leena Sequira |
| Designation |
Principal |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Manipal School of Nursing, MCON,Manipal Academy of Higher Education
Shankerpura post.
Udupi Taluk and district.
574115
KARNATAKA
576104
India |
| Phone |
9481971214 |
| Fax |
|
| Email |
leena.sequ@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Leena Sequira |
| Designation |
Principal |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Manipal School of Nursing, MCON,Manipal Academy of Higher Education
Shankerpura post.
Udupi Taluk and district.
574115
KARNATAKA
576104
India |
| Phone |
9481971214 |
| Fax |
|
| Email |
leena.sequ@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education |
|
|
Primary Sponsor
|
| Name |
Dr Leena Sequira |
| Address |
Principal, Manipal school of Nursing, MCON,MAHE |
| Type of Sponsor |
Other [Deemed University] |
|
|
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 |
| SHALINI G NAYAK |
Manipal school of nursing |
5th floor. Conference room, Room no.502,
Udupi
KARNATAKA |
9481375675
shalini.mcon@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening for the experiences |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Nurses taking care of patients diagnosed with COVID 19 at least for one week.
2. Willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Nurses taking care of patients diagnosed with COVID 19 less than one week.
2.Not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Experiences of giving care to a COVID 19 patient |
Baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/10/2020 |
| 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="1"
Months="0"
Days="0" |
|
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
|
COVID 19 pandemic is increasing globally. This pandemic exerts a considerable impart on health care delivery. Nurses are the front line warriors in the health care system. There is a need for better understanding of nurses experience in caring for the patient affected by COVID 19.The findings will help to identify the problems that have significant impact on nurses, which will further help to develop an intervention that will enhance their wellbeing. |