| CTRI Number |
CTRI/2025/01/079739 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Pre-Post Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact of an Education Program on Awareness about Heart Diseases in School Students in Urban Areas |
|
Scientific Title of Study
|
Effect of Education-based Intervention Program on Awareness Regarding Cardiovascular Disease Among Adolescents in Urban Schools: A Pre-Post 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 |
Dr. Reshma Gurung |
| Designation |
Masters of Physiotherapy student |
| Affiliation |
Sikkim Manipal College of Physiotherapy |
| Address |
Central Referral Hospital, Department of Physiotherapy, 5th floor, 5th Mile Tadong, Gangtok
East
SIKKIM
737102
India |
| Phone |
06295734030 |
| Fax |
|
| Email |
kimtisherpa2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Reshma Gurung |
| Designation |
Masters of Physiotherapy student |
| Affiliation |
Sikkim Manipal College of Physiotherapy |
| Address |
Central Referral Hospital, Department of Physiotherapy, 5th floor, 5th Mile, Tadong, Gangtok, East Sikkim
East
SIKKIM
737102
India |
| Phone |
06295734030 |
| Fax |
|
| Email |
kimtisherpa2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Reshma Gurung |
| Designation |
Masters of Physiotherapy student |
| Affiliation |
Sikkim Manipal College of Physiotherapy |
| Address |
Central Referral Hospital, Department of Physiotherapy, 5th floor, 5th Mile, Tadong, Gangtok
SIKKIM
737102
India |
| Phone |
06295734030 |
| Fax |
|
| Email |
kimtisherpa2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Referral Hospital, 5th Mile, Tadong, East Sikkim, India, 737102 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Reshma Gurung |
Central Referral Hospital, 5th Mile, Tadong, East Sikkim, India, 737102 |
Central Referral Hospital, Department of Physiotherapy, 5th floor, 5th Mile, Tadong, Gangtok, East Sikkim
East
SIKKIM |
06295734030
kimtisherpa2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS INSTITUTION ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
High school children belonging to 9, 10, 11 and 12 standard |
|
| ExclusionCriteria |
| Details |
Absent from either pre test, study session or post test, not willing to participate, no consent given from parents |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Awareness regarding Cardiovascular health in school-going children questionnaire |
follow up (pre post study)
At baseline, After the education program on the same day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
15/02/2025 |
| 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)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
In this study, I will be obtaining approval from the ethical committee of the institute and permissions from all participating schools before commencing the research. Once permissions are granted, students will be screened for eligibility based on predefined criteria. Eligible students will first complete a pretest questionnaire to assess their initial awareness of cardiovascular diseases. Following this, I will conduct an educational class featuring a Microsoft PowerPoint presentation, which will include educational pictures and videos accompanied by simple explanations to ensure clear understanding. Eight weeks later, the same set of students will complete a post-test using the same questionnaire to measure the effectiveness of the educational intervention in enhancing their awareness. |