| CTRI Number |
CTRI/2023/11/059863 [Registered on: 15/11/2023] Trial Registered Prospectively |
| Last Modified On: |
31/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of stress in college going students. |
|
Scientific Title of Study
|
Prevalence of academic stress and coping up strategies in students pursuing undergraduate health sciences program |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandani Ahir |
| Designation |
1st year MPT |
| Affiliation |
College of Physiotherapy Sumandeep Vidyapeeth deemed to be University |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be Univeristy, Piparia, Waghodia, Vadodara, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
7265823689 |
| Fax |
|
| Email |
nandaniahir18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G P Kumar |
| Designation |
Dean |
| Affiliation |
College of Physiotherapy Sumandeep Vidyapeeth deemed to be University |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be Univeristy, Piparia, Waghodia, Vadodara, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8238034454 |
| Fax |
|
| Email |
principal.physiotherapy@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr G P Kumar |
| Designation |
Dean |
| Affiliation |
College of Physiotherapy Sumandeep Vidyapeeth deemed to be University |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be Univeristy, Piparia, Waghodia, Vadodara, 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8238034454 |
| Fax |
|
| Email |
principal.physiotherapy@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Nandani Ahir
COLLEGE OF PHYSIOTHERAPY SUMANDEEP VIDYAPEETH DEEMED TO BE UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
Nandani Ahir |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be Univeristy, Piparia, Waghodia, Vadodara, 391760 |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 |
| Nandani Ahir |
Constituent Institutes of Sumandeep Vidyapeeth |
College of Physiotherapy, Sumandeep Vidyapeeth deemed to be University Piparia, Waghodia, Vadodara 391760
Vadodara
GUJARAT |
7265823689
nandaniahir18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
Undergraduates health sciences students of both gender between age of 18-28 years. Individuals who read, write and understand English |
|
| ExclusionCriteria |
| Details |
Students pursuing any other courses pther than undergraduate healthsciences program. Any other factors affecting mental status like personal, social, financial or family factors. Individuals who is known case of any other pyschomotor illness. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Academic Stress Inventory
|
1:time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stress Coping Style Inventory |
1:time |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "454"
Final Enrollment numbers achieved (India)="454" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/11/2023 |
| Date of Study Completion (India) |
22/03/2025 |
| Date of First Enrollment (Global) |
27/11/2023 |
| Date of Study Completion (Global) |
22/03/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In this study the undergraduate students will be approached in group and will be explained about the study. Interested individuals will be included if fulfills inclusion. They will be given Academic Stress Inventory and Stress Coping Style Inventory. They have to read questions carefully and tick appropriate answers. The data will be statistically analysed. |