| CTRI Number |
CTRI/2023/02/049489 [Registered on: 06/02/2023] Trial Registered Prospectively |
| Last Modified On: |
10/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive Survey |
| Study Design |
Other |
|
Public Title of Study
|
A survey to find out the internet use, risky online behavior and safety measures among school children of kundapura taluk. |
|
Scientific Title of Study
|
Descriptive survey to assess the internet use, risky online behavior and safety measures among school children in selected schools of Kundapura taluk, Udupi. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JENNIFER FREEDA MENEZES |
| Designation |
Student |
| Affiliation |
College of Manipal Nursing |
| Address |
M.Phil. Nursing
Manipal College of Nursing, Madhav Nagar
Manipal
Udupi
KARNATAKA
5766104
India |
| Phone |
9886153555 |
| Fax |
|
| Email |
diyadeep182@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RENJULAL YESODHARAN |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Manipal College of Nursing |
| Address |
Manipal College of Nursing, Madhav Nagar
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8095900592 |
| Fax |
|
| Email |
renjulal.y@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
LAXMINARAYAN IYER |
| Designation |
Associate Professor |
| Affiliation |
Sowkya College of Nursing |
| Address |
Room no 309, 3rd floor, Sowkya College of Nursing, Madhuvana Achalady
Udupi
Room no 309, 3rd floor, Sowkya College of Nursing, Madhuvana Achalady
Udupi
Udupi
KARNATAKA
576223
India |
| Phone |
9611684413 |
| Fax |
|
| Email |
luckylmi88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal college of Nursing
Madhav Nagar, Manipal
Udupi District - 576104 |
|
|
Primary Sponsor
|
| Name |
JENNIFER FREEDA MENEZES |
| Address |
Maniapl College of Nursing
Madhav nagar
Manipal - 576104
|
| Type of Sponsor |
Other [Primary Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jennifer Menezes |
Bearys Seaside Public School |
Beach Road, Kodi-Kundapura
Udupi
KARNATAKA |
9448618329
uahsbearysseasidekodi@gmail.com |
| Jennifer Menezes |
Government High School |
Vakvadi, Koteshwara
Udupi
KARNATAKA |
8861365575
ghsvakwady@gmai.com |
| Jennifer Menezes |
Government higher primary and high school |
Shankarnarayana, Kundapura
Udupi
KARNATAKA |
9448649709
ghshankarn99@gmail.com |
| Jennifer Menezes |
Mother Theresa Memorial School |
Shankarnaraya, Kundapura
Udupi
KARNATAKA |
9844300232
motherteresaschool2000@yahoo.in |
| Jennifer Menezes |
S R V K English medium School |
Kodi, Kundapura
Udupi
KARNATAKA |
8197652485
kodisrv@gmail.com |
| Jennifer Menezes |
S.V English Medium School |
Gangolli, Kundapura
Udupi
KARNATAKA |
9986754203
svemschool13@gmail.com |
| Jennifer Menezes |
S.V Kannada Medium school |
Gangolli, Kundapura
Udupi
KARNATAKA |
9901201090
svemschool13@gmail.com |
| Jennifer Menezes |
St. Marys kannada Medium School |
Vaderhobali, Kundapura
Udupi
KARNATAKA |
9481749357
ahpsstmaryskundapura@gmail.com |
| Jennifer Menezes |
St.Pius X higher primary and high School |
Piusnagar, Hanglur
Koteshwara, Kundapura
Udupi
KARNATAKA |
9480763832
stpiusxhanglur@gmail.com |
| Jennifer Menezes |
V K R Acharya Memorial English Medium School |
Vaderhobali, Kundapura
Udupi
KARNATAKA |
8548806765
chinthanarajesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committe - 2 |
Approved |
| localnoc |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 10 to 16 years attending schools.
Children who know to read and write Kannada and English.
|
|
| ExclusionCriteria |
| Details |
Children who are not available during data collection and not willing to participate.
Mothers and children who are not willing to give consent and assent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessing the internet use, online activity and risky online behavior. |
Base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessing safety measures to protect the child from future online risk. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="1020"
Sample Size from India="1020"
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)
|
06/02/2023 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In today’s world, the internet is one of the most widely used technologies. In India 70 percent of youth spend more than 5 hours on the internet in a usual week. In terms of social networking platforms, India’s youth are constantly connected via Facebook (93%), YouTube (87%), WhatsApp (79%) etc. (Mcafee 2014). According to Dowell, Burgess and Cavanaugh (2009) and Livingstone with Colleagues (2011) communicating with strangers, dangerous sexual behavior, revealing personal information, cyberbullying and access to age-inappropriate web pages are among the most common forms of risky behavior on internet. India is a developing country and its important to keep in mind that schoolchildren and teenagers, who are at the age of puberty lack knowledge and are most likely to engage in risky online behavior. So, the investigator wants to determine the degree or extent to which online risk is prevalent among school children so that it can be controlled to ensure safety of the children and save them from hazard of online activity. |