| CTRI Number |
CTRI/2024/11/076165 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlational Study |
| Study Design |
Other |
|
Public Title of Study
|
What is the Impact of Mental Fatigue and Depression on Executive Function and Academic Performance of class 9th to class 12th Students |
|
Scientific Title of Study
|
Relationship between Self Perceived Stress, Mental Fatigue, Executive Function and Academic Performance in High School Students
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikha Kumari |
| Designation |
Postgraduate Resident |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Amar Jyoti Institute of Physiotherapy(Amar Jyoti Rehabilitation and Research Centre) Karkardooma, Vikas Marg, Delhi 110092
East
DELHI
110092
India |
| Phone |
8285483310 |
| Fax |
|
| Email |
shikhakumari9900@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Preksha Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Amar Jyoti Institute of Physiotherapy(Amar Jyoti Rehabilitation and Research Centre) Karkardooma, Vikas Marg, Delhi 110092
East
DELHI
110092
India |
| Phone |
9990640376 |
| Fax |
|
| Email |
preksha994@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Preksha Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Amar Jyoti Institute of Physiotherapy |
| Address |
Amar Jyoti Institute of Physiotherapy(Amar Jyoti Rehabilitation and Research Centre) Karkardooma, Vikas Marg, Delhi 110092
East
DELHI
110092
India |
| Phone |
9990640376 |
| Fax |
|
| Email |
preksha994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amar Jyoti Institute of Physiotherapy, Karkardooma, Vikas Marg, Delhi 110092 |
|
|
Primary Sponsor
|
| Name |
Shikha Kumari |
| Address |
Amar Jyoti Institute of Physiotherapy (Amar Jyoti Rehabilitation and Research Cntre) Karkardooma, Vikas Marg Delhi 110092 |
| 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 |
| Dr Preksha Sharma PT |
Sarvodaya Co-Ed Vdyalaya |
Shiva Road, Pocket 15, Sector 8, Rohini, Delhi 110085
North West
DELHI |
9990640376
preksha994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Amar Jyoti Institutional Review Board- Ehical Committee |
Approved |
| Govt. Sarvodaya Co-Ed Vidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress, Mental Fatigue and Executive Function |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Class 9th to class 12th students with age range 13 to 17 years.
Attended last two Unit test.
Fulfilling 75% attendance criteria.
Able to read , speak and understand English.
Both Genders. |
|
| ExclusionCriteria |
| Details |
History of hospital admission in last 6 months.
Currently on any anti-psychotic medication.
History of psychiatric disorder
Students with colour blindness |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Perceived Stress Scale-10 (PSS-10)
2. Depression Anxiety Stress Scale 21 (DASS-21)
3. Mental Fatigue Scale (MFS)
4. Stroop Colour and Word Test
5. Trail Making Test (TMT Part A and B)
6. Scores from last 2 examination |
1. Perceived Stress Scale-10 (PSS-10) - Baseline Level
2. Depression Anxiety Stress Scale 21 (DASS-21) - Baseline Level
3. Mental Fatigue Scale (MFS) - Baseline Level
4. Stroop Colour and Word Test - Baseline Level
5. Trail Making Test (TMT Part A and B) - Baseline Level
6. Scores from last 2 examination - Baseline Level |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
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)
|
02/12/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Collaboration with school to recruit a diverse sample of students from class 9th to 12th aged 13-17 years. Informed assent
from participants and consent from their parents/guardians will be ensured. Data for Perceived Stress and Mental Fatigue will be collected using Perceived Stress scale (PSS-10), Depression Anxiety Stress Scale 21 (DASS-21) and Mental fatigue scale. Executive function of the students will be measured using Stroop Colour and Word Test and Trail Making Test. Marks of last 2 examination will be collected for each student from School to measure Academic Performance. Data will be recorded and analyzed using SPSS to see the relationship between all variables. |