| CTRI Number |
CTRI/2023/09/058124 [Registered on: 29/09/2023] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
"Impact Of Psychological Changes In School Going Children."
IN SCHOOL GOING CHILDREN" |
|
Scientific Title of Study
|
"Prevalence Of Psychological Changes In School Going Children-A Hospital Based Cross sectional study" |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G Sneka |
| Designation |
PG Scholar |
| Affiliation |
National institute of siddha |
| Address |
National institute of siddha,
Department of kuzhanthai Maruthuvam,
Branch 4
Tambaram sanatorium,
Chennai.
Dr.M.Meenakshi sundaram,
Professor and HOD
Department of kuzhanthai Maruthuvam, Branch IV,Tambaram sanatorium,Chennai 47
Chennai
TAMIL NADU
600047
India |
| Phone |
9865396880 |
| Fax |
|
| Email |
snekasne1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M.Meenakshi sundaram |
| Designation |
HOD and professor |
| Affiliation |
National institute of siddha |
| Address |
National institute of siddha, Department of kuzhanthai Maruthuvam,Tambaram sanatorium,chennai.
Chennai
TAMIL NADU
600047
India |
| Phone |
9865396880 |
| Fax |
|
| Email |
mmssiddha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
G Sneka |
| Designation |
PG Scholar |
| Affiliation |
National institute of siddha |
| Address |
National institute of siddha, Department of kuzhanthai Maruthuvam,Tambaram sanatorium,chennai.
Chennai
TAMIL NADU
600047
India |
| Phone |
9865396880 |
| Fax |
|
| Email |
snekasne1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| "National institute of siddha" |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA,
TAMBARAM SANATORIUM,
CHENNAI -600046. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 G Sneka |
Ayothidass pandidhar hospital |
National institute siddha,
Department of kuzhanthai Maruthuvam,Branch IV,
Tambaram sanatorium
Chennai
Chennai
TAMIL NADU |
9865396880
snekasne1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F419||Anxiety disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Willing to give consent and assent to participate in the study |
|
| ExclusionCriteria |
| Details |
Participants under treatment for mental related disorder .
Not willing to participate in the study
Participants with known medical history of brain related disorder.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| "Psychological changes may differ mild to moderate in school going children " |
2 months screening
2 months Patient Assessment
2 months Outcome Assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| "Factors influencing psychological changes may be noted" |
2 months screening
2 months Patient Assessment
2 months Outcome Assessment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/10/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Globally, mental health problems account for 13% of the total burden of disease, For most mental health disorders their first onset occurs in childhood or adolescence. Approximately half of those with mental health disorders first experience the corresponding symptoms at approximate age 14. These early onsets of mental disorders have been accounted for a variety of adverse consequences, such as disruption of education and early career development of affected individuals.
Psychological distress is defined as a state of emotional suffering characterized by the undifferentiated combinations of symptoms of depression (eg, lost interest; sadness; hopelessness) and anxiety (eg, restlessness; feeling tense) which are sometimes accompanied by somatic symptoms (eg, insomnia; headaches; lack of energy). Psychological distress among adolescent students is common in developed as well as in developing countries, and is a major public health challenge.
This can be associated with undesirable mental health that affects their level of functionality and for many it impacts on educational achievement as well as the total health of adolescents, thereby having a substantial effect on opportunities in adult life.
While psychological distress among school adolescent has been well researched in developed countries, very few studies are available in the south Indian region particularly in Tamilnadu .There is no published study that reflects the current status of psychological distress among secondary school students in Tamilnadu. Therefore, this study is aimed to determine the prevalence of psychological distress and identify the associated factors of psychological distress among school students.
|