| CTRI Number |
CTRI/2021/03/032086 [Registered on: 17/03/2021] Trial Registered Prospectively |
| Last Modified On: |
16/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the mental health status, job satisfaction and quality of sleep among nursing staff during COVID 19 pandemic |
|
Scientific Title of Study
|
To study the level of perceived stress, Job satisfaction, quality of sleep among nursing staff and compare with various cadre of nursing staff. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Santosh Ramdurg |
| Designation |
Associate Professor |
| Affiliation |
BLDE Hospital and Research Centre |
| Address |
Department of Psychiatry
BLDE Hospital and Research Centre,
Vijayapura.
Department of Psychiatry
BLDE Hospital and Research Centre,
Vijayapura.
Bijapur
KARNATAKA
586103
India |
| Phone |
9611281386 |
| Fax |
|
| Email |
santoshramdurg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANTOSH RAMDURG |
| Designation |
Associate Professor |
| Affiliation |
BLDE HOSPITAL AND RESEARCH HOSPITAL |
| Address |
Department of Psychiatry
BLDE Hospital And Research Centre,
Vijayapura
Department of Psychiatry
BLDE Hospital And Research Centre,
Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
9611281386 |
| Fax |
|
| Email |
santoshramdurg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANTOSH RAMDURG |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
BLDE HOSPITAL AND RESEARCH HOSPITAL |
| Address |
DEPT OF OBG
OPD NO 2
BLDE HOSPITAL AND RESEARCH CENTRE,
VIJAYAPURA
DEPT OF PSYCHIATRY
BLDE HOSPITAL AND RESEARCH CENTRE,
VIJAYAPURA
Bijapur
KARNATAKA
586103
India |
| Phone |
9611281386 |
| Fax |
|
| Email |
santoshramdurg@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR SANTOSH RAMDURG
Department Of Psychiatry
BLDE Hospital and Research Centre,
Vijayapura |
|
|
Primary Sponsor
|
| Name |
Dr Santosh Ramdurg |
| Address |
Department of Psychiatry
BLDE Hospital and Research Centre,
Vijayapura. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr S R Mudanur |
Department of Obstetrics and Gynaecology
OPD NO 2
BLDE HOSPITAL AND RESEARCH CENTRE,
VIJAYAPURA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santosh Ramdurg |
Medical Institutes And Private Hospitals all over India |
Department of Psychiatry
BLDE Hospital and Research Centre,
Vijayapura.
Bijapur
KARNATAKA |
9611281386
santoshramdurg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE UNIVERSITY ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z208||Contact with and (suspected) exposure to other communicable diseases, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All the nursing staff working within the institute and those who are working in private set-up around Vijayapura and surrounding places |
|
| ExclusionCriteria |
| Details |
no specific criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study the metal state of the nursing staff under the conditions of Covid -19 |
o weeks , 4 weeks , 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
20/03/2021 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
study helps to know the status of the health workers, specially the nursing
staff about the problems faced on a daily basis at their work places.
Also, the challenges
faced economically and socially are also taken into consideration.
This study helps us
to know the condition of these health workers and helps us understand that
similar challenges must be faced all over the globe, helps us to reach out and
be a better person.
|