| CTRI Number |
CTRI/2022/01/039841 [Registered on: 31/01/2022] Trial Registered Prospectively |
| Last Modified On: |
05/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on anxiety due to exams among 10th and 12th class students during the COVID-19. |
|
Scientific Title of Study
|
A cross sectional study on exam related anxiety among senior high school students during the COVID-19 pandemic in Aligarh, Uttar Pradesh. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanya Nelson Singh |
| Designation |
BDS, MPH (pursuing) |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room no: 62, Department of Health Policy, Prasanna School of Public Health, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9557791466 |
| Fax |
|
| Email |
tanya.singh13@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Arathi Rao |
| Designation |
MBBS, DGO, MPH, PhD |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room no: 60, Department of Health Policy, Prasanna School of Public Health, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008418848 |
| Fax |
|
| Email |
arathi.anil@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Tanya Nelson singh |
| Designation |
BDS, MPH (pursuing) |
| Affiliation |
Prasanna School of Public Health |
| Address |
Room no: 62, Department of Health Policy, Prasanna School of Public Health, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9557791466 |
| Fax |
|
| Email |
tanya.singh13@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Health Policy, Prasanna School of Public Health, MAHE, Manipal |
|
|
Primary Sponsor
|
| Name |
Tanya Nelson Singh |
| Address |
Room no: 62, Department of Health Policy, Prasanna School of Public Health, MAHE, Manipal |
| Type of Sponsor |
Other [Self funded study] |
|
|
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 |
| Anurita Singh |
Ingraham Institute Senior Secondary English School |
Room No: 2, Principal office, Ingraham Institute campus, near RTO office, G T road
Aligarh
UTTAR PRADESH |
9557791462
principal@ingrahaminstitutealigarh.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Senior High School Students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
All the students of class 10th, and 12th appearing in the year 2022 exams. |
|
| ExclusionCriteria |
| Details |
Students studying in junior high, and in class 11th
and the students who are taking any anti-anxiety medication.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will generate evidence of exam related anxiety in senior high school students. |
Eight weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="356"
Sample Size from India="356"
Final Enrollment numbers achieved (Total)= "340"
Final Enrollment numbers achieved (India)="340" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/02/2022 |
| Date of Study Completion (India) |
17/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
According to Centers
for Disease Control and Prevention (CDC), anxiety can be present in children as
fear or worry (phobia), being very
afraid of school (social anxiety), and being very worried about the future (general
anxiety). The study involves 356 students of
class 10th and 12th who will be
appearing in the year 2022 exams are eligible to participate in this study after seeking the permission from the schools and taking the consent from the parents, the data collection will be carried out through face-to-face.
|