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CTRI Number  CTRI/2023/10/058965 [Registered on: 20/10/2023] Trial Registered Prospectively
Last Modified On: 13/09/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Examining the Influence of Screen Time and Indoor Activities on Anxiety, Behavior, and Academic Performance in Schoolchidren 
Scientific Title of Study   Impact of Screen time and Indoor activities on Anxiety and Behavior Patterns on Academic Performance among Schoolchildren- A Cross Sectional 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 Mohammad Siidq 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Room No B-316, Department of Physiotherapy, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Yamuna Expy, Greater Noida, Uttar Pradesh India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammad Siidq 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Room No B-316, Department of Physiotherapy, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Yamuna Expy, Greater Noida, Uttar Pradesh India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Details of Contact Person
Public Query  
Name  Professor Dr Aksh Chahal 
Designation  Professor  
Affiliation  Galgotias University 
Address  Room No B-512, Department of Physiotherapy, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Yamuna Expy, Greater Noida, Uttar Pradesh India

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9711774174  
Fax    
Email  drakshchahal@gmail.com  
 
Source of Monetary or Material Support  
Room No A315,Research and Development Cell, Galgotias University, Plot No 2, Sector 17A, Yamuna Expy, opposite Buddha International circuit, Greater Noida Uttar Pradesh 203201 
 
Primary Sponsor  
Name  Galgotias University 
Address  Plot No 2, Sector 17A, Opposite Buddha International Circuit, Yamuna Expy, Greater Noida India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Dr Aksh Chahal  Room No E003, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University  Plot No 2, Sector 17A, Opposite Gautam Buddha International Circuit, Yamuna expressway, Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH 		 9711774174

drakshchahal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Ethics Committee, Galgotias University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F919||Conduct disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Age Group: Participants should be schoolchildren aged between 2 and 21 years old,
Academic Performance Data: Participants should have available academic performance data, such as grade point average (GPA) or standardized test scores.

Screen Time and Indoor Activities: Participants should be engaging in varying levels of screen time and indoor activities, including but not limited to watching television, using computers, playing video games, and participating in indoor recreational activities.

Anxiety and Behavior Patterns: Participants should be assessed for anxiety and behavior patterns using standardized and validated assessment tools or questionnaires, such as the State-Trait Anxiety Inventory for Children (STAIC) and the Strengths and Difficulties Questionnaire (SDQ).

School Attendance: Participants should attend regular, mainstream educational institutions. 
 
ExclusionCriteria 
Details  Exclusion Criteria:
1. Age Group: Participants outside the specified age range (below 6 or above 18 years old) should be excluded.
2. Lack of Academic Performance Data: Participants without available academic performance data, such as GPA or standardized test scores, should be excluded.
3. Screen Time and Indoor Activities: Participants who do not engage in any screen time or indoor activities should be excluded, as this study aims to investigate the impact of these activities.
4. Preexisting Mental Health Conditions: Participants with preexisting mental health conditions, such as diagnosed anxiety disorders or behavioral disorders, should be excluded to isolate the impact of screen time and indoor activities.

5. Special Education Settings: Participants in special education settings or with special needs that significantly affect their academic performance should be excluded, as these factors may confound the results.
6. Lack of Relevant Data: Studies lacking relevant data on screen time, indoor activities, anxiety, behavior patterns, or academic performance will be excluded from the analysis.
7. Non-Schoolgoing Population: Participants who are not enrolled in mainstream educational institutions.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Anxiety
Behavior Patterns
Academic Performance 		 Baseline(One Point assessment) 
 
Secondary Outcome  
Outcome  TimePoints 
Academic performance  Baseline & 2 months 
 
Target Sample Size   Total Sample Size="377"
Sample Size from India="377" 
Final Enrollment numbers achieved (Total)= "537"
Final Enrollment numbers achieved (India)="537" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/10/2023 
Date of Study Completion (India) 14/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Introduction

In the modern digital age, schoolchildren are increasingly exposed to screens and indoor activities. The proliferation of smartphones, tablets, computers, and video games has led to a significant rise in screen time among children. While technology has its benefits, excessive screen time and limited outdoor activities have raised concerns about their impact on children’s mental health and academic performance. This proposal outlines a research study to investigate the influence of screen time and indoor activities on anxiety levels and academic performance among schoolchildren in Greater Noida, India.

Objectives

The primary objectives of this research study are as follows:

1. To assess the extent of screen time and indoor activity engagement among schoolchildren in Greater Noida, India.

2. To examine the relationship between screen time and indoor activities with anxiety levels among schoolchildren.

3. To investigate how screen time and indoor activities affect the academic performance of schoolchildren.

4. To provide recommendations for parents, educators, and policymakers to mitigate potential negative effects.

Methodology

1. Sampling

Sample size was calculated using Raosoft sample size calculator using 5% of margin of error, with a 95% confidence interval and 50% response distribution, the total sample size calculated was 377.A random sample of schoolchildren (grades 1-12) will be selected from various schools in Greater Noida, ensuring representation from different socioeconomic backgrounds and educational institutions.

2. Data Collection

 

2.1. Surveys and Questionnaires

Participants will be asked to complete surveys and questionnaires, including:

- A screen time log to record daily device usage.

- An anxiety assessment questionnaire (SPENCE CHILDREN’S ANXIETY SCALE)

- Academic performance records (grades, test scores, and attendance).

 2.2. Interviews

In-depth interviews will be conducted with a subset of participants and their parents/guardians to gain insights into their screen time habits, indoor activities, and the perceived impact on anxiety and academic performance.

3. Data Analysis

Statistical analysis will be carried out using appropriate software (e.g., SPSS or R). The following analyses will be performed:

- Descriptive statistics to summarize screen time, indoor activities, anxiety levels, and academic performance.

- Correlation and regression analysis to identify relationships between variables.

- Qualitative analysis of interview data to understand the subjective experiences and perspectives of participants.

4. Ethical Considerations

Ethical approval was obtained from Departmental Ethics Committee Ref:DEC/FEA/PT/06/23.- Informed consent will be obtained from participants and their parents/principal or class teacher.

- Data confidentiality and anonymity will be ensured.

- The study will adhere to ethical guidelines for research involving human subjects.

Expected Outcomes

The research aims to provide valuable insights into the impact of screen time and indoor activities on anxiety levels and academic performance among schoolchildren in Greater Noida. The findings may reveal correlations, contributing factors, and potential consequences. The expected outcomes include:

1. A better understanding of how screen time and indoor activities affect the well-being of schoolchildren.

2. Identification of risk factors and protective factors related to anxiety and academic performance.

3. Recommendations for parents, educators, and policymakers to promote healthier screen time habits and outdoor activities among schoolchildren.

Conclusion

This research study will contribute to the existing knowledge on the relationship between screen time, indoor activities, anxiety levels, and academic performance among schoolchildren in Greater Noida, India. The findings will have implications for the development of strategies and interventions to support the well-being and educational outcomes of this population. We seek approval and funding to conduct this important research study and make a meaningful impact on the lives of schoolchildren in Greater Noida.


 
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