| CTRI Number |
CTRI/2020/09/027544 [Registered on: 02/09/2020] Trial Registered Prospectively |
| Last Modified On: |
17/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Covid 19 and Professional course students quality of life |
|
Scientific Title of Study
|
Quality of life during COVID-19 pandemic among professional course students of selected colleges in and around Kolkata ,India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swet Nisha |
| Designation |
Assistant professor |
| Affiliation |
Haldia Institute Of Dental Sciences and Research |
| Address |
Haldia Institute of dental sciences and research,Department of Periodontology , Division of Dentistry.
Balughata banbishnupur
Medinipur
WEST BENGAL
banbishnupur,balughata
Medinipur
WEST BENGAL
700052
India |
| Phone |
07595800724 |
| Fax |
|
| Email |
swetnisha1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arnab Ganguly |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Hygiene and Public health |
| Address |
All India Institute Of Hygiene And Public Health,Department of Epidemiology ,room no.7.
Block JC 27 And 27b Sector III Bidhannagar Division
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL
700106
India |
| Phone |
9051721216 |
| Fax |
|
| Email |
drarnabgangulymd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arnab Ganguly |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Hygiene and Public health |
| Address |
All India Institute Of Hygiene And Public Health,Department of Epidemiology ,room no.7.
Block JC 27 And 27b Sector III Bidhannagar Division
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL
700106
India |
| Phone |
9051721216 |
| Fax |
|
| Email |
drarnabgangulymd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swet Nisha
Haldia Institute of dental sciences and research,Department Of Periodontology,Room no.9.,Banbishnupur,P.O-Balughata,Haldia-721645. |
|
|
Primary Sponsor
|
| Name |
Swet Nisha |
| Address |
Haldia Institute of dental sciences and research |
| 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 |
| Swet Nisha |
Haldia Institute of Dental Sciences And Research, |
Haldia Institute of dental sciences and research Department Of Periodontology,Division of Dentistry,Room no 9
Medinipur
WEST BENGAL |
07595800724
swetnisha1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Haldia institute of dental sciences and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
systemically healthy |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years
Citizen of India
Must be enrolled in any full time Undergraduate or postgraduate course |
|
| ExclusionCriteria |
| Details |
Age less than 18 years
Not Indian Citizen
Discontinued studies or not enrolled in full time course. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determination of Quality of Life of Professional Students during Covid-19 Pandemic |
Baseline Data collection to 8 weeks time interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Individuals mastery of life |
Baseline data collection to 8 weeks time interval |
|
|
Target Sample Size
|
Total Sample Size="636"
Sample Size from India="636"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to determine the quality of life among professional course students during COVID-19 pandemic in and around kolkata city. A total of 636 subjects will be enrolled in this study using stratified random sampling method. Questionnaire will be generated by web based survey . study duration will be of 8 weeks time interval and data analysis will be done using SPSS . |