| CTRI Number |
CTRI/2025/04/084624 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [EDUCATIONAL INTERVENTION BY HEALTH EDUCATION] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CHANGE IN PERCEPTION REGARDING SKIN CARE FOLLOWING HEALTH EDUCATION AMONG TEENAGE SCHOOL GOING CHILDREN OF SOUTHERN PART OF THIRUVANANTHAPURAM, KERALA. |
|
Scientific Title of Study
|
EFFECTIVENESS OF AN EDUCATIONAL INTERVENTION IN CHANGING THE KNOWLEDGE, ATTITUDE AND PRACTICE REGARDING SKIN CARE AMONG TEENAGE SCHOOL GOING CHILDREN OF SOUTHERN PART OF THIRUVANANTHAPURAM, KERALA. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joel Tobin |
| Designation |
Post graduate student |
| Affiliation |
Dr. Somervell Memorial CSI Medical College Hospital, Karakonam |
| Address |
Room No 268
Department of Dermatology
Dr. Somervell Memorial CSI Medical College Hospital, Karakonam
Parassala Vellarada Rd, Karakonam, Kerala
Thiruvananthapuram
KERALA
695504
India |
| Phone |
8547851908 |
| Fax |
|
| Email |
joeltobinm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Joan Felicita Samson |
| Designation |
Professor |
| Affiliation |
Dr. Somervell Memorial CSI Medical College Hospital, Karakonam |
| Address |
Room no 266
Department of dermatology
Dr. Somervell Memorial CSI Medical College Hospital, Karakonam
Parassala Vellarada Rd, Karakonam, Kerala
Thiruvananthapuram
KERALA
695504
India |
| Phone |
9846045036 |
| Fax |
|
| Email |
dr.joanfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Joel Tobin |
| Designation |
Post graduate student |
| Affiliation |
Dr. Somervell Memorial CSI Medical College Hospital, Karakonam |
| Address |
Room no 268
Department of dermatology
Dr. Somervell Memorial CSI Medical College Hospital, Karakonam
Parassala Vellarada Rd, Karakonam, Kerala
Thiruvananthapuram
KERALA
695504
India |
| Phone |
8547851908 |
| Fax |
|
| Email |
joeltobinm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr SMCSI MEDICAL COLLEGE KARAKONAM
TRIVANDRUM
KERALA
INDIA
PIN code : 695504
|
|
|
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 |
| Joel Tobin |
Dr Somervell Memorial CSI Medical College Hospital Karakonam |
Room no 268
Department of dermatology
Thrissur
KERALA |
8547851908
joeltobinm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HUMAN ETHICS COMMITTEE Dr. S.M. C.S.I. MEDICAL COLLEGE KARAKONAM, THIRUVANANTHAPURAM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All students of grade VIII to XII of selected schools. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EDUCATIONAL INTERVENTION |
A detailed interactive session using power point presentations and pamphlets which provide basic information on routine skincare practices, malpractices, and myths will be taken. |
| Comparator Agent |
We are comparing the same group in change in knowledge attitude and practice regarding skin care based on health education provided. |
We are comparing the same group in change in knowledge attitude and practice regarding skin care based on health education provided. And we will assess the change after time period of 3 months. Hence health education is the standard of operation. As we are giving health education in the same group we don’t have a comparator agent |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
All students of grade VIII to XII of selected schools. |
|
| ExclusionCriteria |
| Details |
Students whose parents are hesitant to provide consent, or who are themselves hesitant to give assent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess baseline knowledge, attitudes, and practices (KAP) among students before a health education intervention on skin care among teenage school going children and evaluate changes after three months. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the factors associated with the change in knowledge, attitude, & practices related to skin care among teenage school-going children following the educational intervention. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
16/06/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
MATERIALS AND METHODS An educational interventional study will be conducted in the Grade VIII and XII students of the senior secondary schools of the Trivandrum district. Those students fulfilling the inclusion criteria shall be enrolled into the study after getting informed written consent from parents and informed assent from the students. The assessment will be conducted in two sessions as part of a medical camp involving dermatologists. Before the awareness class, students will be given a predesigned and pretested semi-structured self-administered questionnaire that includes socio-demographic variables, exposure to mass media, their current knowledge, and myths about skincare practices. This questionnaire can be completed in 5 minutes. A detailed interactive session using power point presentations and pamphlets which provide basic information on routine skincare practices, malpractices, and myths will follow. A post-test test will be administered three months after the lecture to the same group of students, using the same questions. For each questions fixed marks will be awarded and total marks for both pre and post-test will be analysed. DATA COLLECTION TOOLS A structured pre- and post-awareness questionnaire will be administered, covering socio-demographic variables, knowledge, practices, myths, and general information regarding skin INTERVENTION The intervention will involve classes conducted with the help of PowerPoint presentations. Each class will last approximately 45 minutes and will cover all aspects of skin care knowledge, practices, myths, and general information. All the doubts will be addressed during this session.
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