| CTRI Number |
CTRI/2024/12/078571 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
22/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How screen time of school going students affect their sleep , Anxiety and development related to motor activities |
|
Scientific Title of Study
|
The Impact of Screen time on Sleep Quality, Anxiety and Motor Skill Development in School Students: An Observational 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 |
Komal Kumari |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201 India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
6200891315 |
| Fax |
|
| Email |
ktdbg1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Komal Kumari |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201 India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
6200891315 |
| Fax |
|
| Email |
ktdbg1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vikas Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201 India
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9811162111 |
| Fax |
|
| Email |
vikassharma.smas@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy, Galgotias university Plot no 2 , yamuna expy, opposite Buddha international circuit, sector 17A Greater Noida UTTAR PRADESH India 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Department of Physiotherapy Galgotias university Plot no. 2 Yamuna expy opposite Buddha international circuit sector 17A Greater Noida Uttar Pradesh pin code 203201 INDIA |
| Type of Sponsor |
Research institution |
|
|
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 Vikas Sharma |
Department of Physiotherapy |
Department of physiotherapy , Room no. - B315 , Galgotias University
Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
9811162111
vikassharma.smas@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| “Departmental research committee†|
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
school going students |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Enrolled in participating schools.
2. Access to digital devices (smartphones, tablets, computers) for screen time activities. |
|
| ExclusionCriteria |
| Details |
1. Students with diagnosed neurological or psychiatric disorders that may affect sleep, anxiety, or motor skills.
2. Students currently receiving treatment or interventions specifically related to screen time impacts.
3. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the relationship between screen time and sleep quality in school students, focusing on duration, onset, and disturbances in sleep patterns. |
1 time study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyze the impact of screen time on anxiety levels in school students.
To assess the effect of screen time on motor skills development, including coordination & fine motor abilities. |
1 Time study through questionnaire |
|
|
Target Sample Size
|
Total Sample Size="330"
Sample Size from India="330"
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)
|
10/01/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
The study,examines how screen time affects students’ health. Excessive screen use, especially before bedtime, disrupts sleep through blue light exposure and overstimulation, leading to cognitive and emotional challenges. It is also linked to higher anxiety levels due to social media pressures and reduced physical activity, which can impair motor skill development.
This cross-sectional observational study will involve 330 students aged 10-18 years, selected through stratified random sampling. Tools like the Pittsburgh Sleep Quality Index (PSQI), Generalized Anxiety Disorder-7 (GAD-7), and Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) will assess sleep quality, anxiety levels, and motor skills, respectively. Statistical analyses will explore the relationships between screen time and outcomes. The findings aim to guide parents, educators, and healthcare professionals in promoting balanced screen habits and enhancing students’ overall well-being.
|