| CTRI Number |
CTRI/2022/01/039425 [Registered on: 14/01/2022] Trial Registered Prospectively |
| Last Modified On: |
13/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the impact of the COVID-19 lockdown on the lives of high school students of Udupi District, Karnataka. |
|
Scientific Title of Study
|
A cross-sectional study to assess the impact of the COVID-19 lockdown on Health-Related Quality of Life, mental well-being and daily routines among high school children in selected schools of Udupi District, Karnataka. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meghna Pandit |
| Designation |
Postgraduate Nursing Student |
| Affiliation |
Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, India |
| Address |
Department of Child Health Nursing, Second Floor, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
8073700025 |
| Fax |
|
| Email |
meghna.pandit.16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binu Margaret E |
| Designation |
Assistant Professor – Selection Grade |
| Affiliation |
Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, India |
| Address |
Department of Child Health Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9844602532 |
| Fax |
|
| Email |
binu.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Binu Margaret E |
| Designation |
Assistant Professor – Selection Grade |
| Affiliation |
Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, India |
| Address |
Department of Child Health Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9844602532 |
| Fax |
|
| Email |
binu.m@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing Manipal Academy of Higher Education, Manipal, Karnataka |
|
|
Primary Sponsor
|
| Name |
Manipal College of Nursing Manipal Academy of Higher Education Manipal |
| Address |
Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Udupi District, Karnataka, India - 576104 |
| Type of Sponsor |
Other [Private Nursing College] |
|
|
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 |
| Meghna Pandit |
Manipal College of Nursing, Manipal Academy of Higher Education, Manipal |
Department of Child Health Nursing, Second Floor, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Udupi District, Karnataka, India - 576104
Udupi
KARNATAKA |
8073700025
meghna.pandit.16@gmail.com |
|
|
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 |
Healthy, high school-going children who have experienced the COVID-19 lockdown |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Children studying in classes 8th to 10th of selected English Medium High Schools of Udupi District, Karnataka, who have experienced the COVID-19 lockdown during the previous two years, who consent to take part, and have their parents’ consent to participate in the study |
|
| ExclusionCriteria |
| Details |
High school students / parents of high school students unwilling to provide consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Health Related Quality of Life (HRQOL) of the children |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mental Well-being and daily routines of the children |
1 year |
|
|
Target Sample Size
|
Total Sample Size="420"
Sample Size from India="420"
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)
|
27/01/2022 |
| 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="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
|
The study is a cross-sectional survey designed to assess the
Health-Related Quality of Life (HRQOL), mental well-being, and daily routines
of students studying in classes 8th to 10th of selected
English Medium High Schools of Udupi District, Karnataka, during the period of
the COVID-19 lockdown in the country. The study also aims to establish a
relationship between the HRQOL and mental well-being of the students. |