| CTRI Number |
CTRI/2025/02/080653 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess how screen time affects preschoolers activity, sleep and thinking skills. |
|
Scientific Title of Study
|
A cross sectional study to assess the screen time sleep outcome physical activity and cognitive development of preschoolers in selected preschools of Udupi District Karnataka |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rechangben Imchen |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Nursing Manipal Academy of Higher Education |
| Address |
Dept. of Child Health Nursing 2nd Floor Manipal College of Nursing MAHE
Manipal
Udupi
Karnataka
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
8486642603 |
| Fax |
|
| Email |
aimchen50@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binu Margaret E |
| Designation |
Assistant Professor (Selection Grade) |
| Affiliation |
Manipal College of Nursing Manipal Academy of Higher Education |
| Address |
Dept. of Child Health Nursing 2nd Floor Manipal College of Nursing MAHE
Manipal
Udupi
Karnataka
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9844602532 |
| Fax |
|
| Email |
binu.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Sheela Shetty |
| Designation |
Assistant Professor (Senior Scale) |
| Affiliation |
Manipal College of Nursing Manipal Academy of Higher Education |
| Address |
Dept. of Child Health Nursing 2nd Floor Manipal College of Nursing MAHE Manipal
Udupi
Karnataka
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9481269426 |
| Fax |
|
| Email |
sheela.shetty@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Self sponsored (Rechangben Imchen) |
|
|
Primary Sponsor
|
| Name |
Rechangben Imchen |
| Address |
Dept. of Child Health Nursing, 1st Floor Manipal College of Nursing, MAHE, Manipal, Karnataka State, India. 576104 |
| 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 Binu Margaret E |
Manipal College of Nursing |
1st floor
Dept. of Child Health Pediatric Nursing
Room no 103
MAHE Manipal
Udupi
Karnataka
576104
India
Udupi
KARNATAKA |
9844602532
binu.m@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preschoolers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Age group of 3 to 5 years
Attending preschools regularly
Parents consenting to participate in the study
Ability to understand the questionnaire in English and Kannada |
|
| ExclusionCriteria |
| Details |
Preschooler diagnosed with developmental disability or any medical condition.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the relationship between Screen time, physical activity, sleep, and cognitive development of preschoolers |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="303"
Sample Size from India="303"
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)
|
24/02/2025 |
| 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)
|
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
|
This
cross-sectional study aims to assess the screen time, sleep outcome, physical
activity, and cognitive development of preschool-aged children and find their
relationship. The findings of the study will give baseline information, which
can be used by the healthcare professionals to educate families and schools to
better anticipate the consequences of promoting a healthy lifestyle, aiding in
the optimal development of preschool children. |