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CTRI Number  CTRI/2022/12/048244 [Registered on: 19/12/2022] Trial Registered Prospectively
Last Modified On: 14/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The attitude and knowledge of parents regarding the effect and usage of laptop, computer, mobile and their usage time on physical health of their children aged between 13-15 years 
Scientific Title of Study   Perception of parents and their children regarding association of screen time and physical health among children aged 13-15 years – A cross sectional study.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  R SRIMANJULA 
Designation  Post Graduate student in Pediatric Physiotherapy 
Affiliation  Mother Theresa Post Graduate and Research Institute of Health Sciences 
Address  Department of Pediatric Physiotherapy College of Physiotherapy Mother Theresa Post Graduate and Research Institute of Health Sciences Indira Nagar Pondicherry
.
Pondicherry
PONDICHERRY
605006
India 
Phone  8508135395  
Fax  0413-2277594  
Email  srimanjula.sm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  RATHISH S 
Designation  ASSISTANT PROFESSOR 
Affiliation  Mother Theresa Post Graduate and Research Institute of Health Sciences 
Address  Head of Department I/C Department of Pediatric Physiotherapy College of Physiotherapy Mother Theresa Post Graduate and Research Institute of Health Sciences Indira Nagar
.
Pondicherry
PONDICHERRY
605006
India 
Phone  9944319384  
Fax  0413-2277594  
Email  rathish@mtpgrihs.ac.in  
 
Details of Contact Person
Public Query  
Name  RATHISH S 
Designation  ASSISTANT PROFESSOR 
Affiliation  Mother Theresa Post Graduate and Research Institute of Health Sciences 
Address  Head of Department I/C Department of Pediatric Physiotherapy College of Physiotherapy Mother Theresa Post Graduate and Research Institute of Health Sciences Indira Nagar
.
Pondicherry
PONDICHERRY
605006
India 
Phone  9944319384  
Fax  0413-2277594  
Email  rathish@mtpgrihs.ac.in  
 
Source of Monetary or Material Support  
Department of Pediatric Physiotherapy College of Physiotherapy Mother Theresa Post Graduate and Research Institute of Health Sciences Indira Nagar Pondicherry 
Rajiv Gandhi Government Women And Childrens Hospital Lakshmi nagr, Lakshmi Nagar, Annamalai Nagar, Puducherry 
 
Primary Sponsor  
Name  R. SRIMANJULA 
Address  Department of Pediatric Physiotherapy College of Physiotherapy Mother Theresa Post Graduate and Research Institute of Health Sciences Puducherry 
Type of Sponsor  Other [Self] 
 
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 
RATHISH S  Mother Theresa Post Graduate and Research Institute of Health Sciences  Room no.103, Paediatric Physiotherapy lab, I Floor, Mother Theresa Post Graduate and Research Institute of Health Sciences, Indira Nagar Gorimedu
Pondicherry
PONDICHERRY 		 9944319384
0413-2277594
rathish@mtpgrihs.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RGGW&CH INSTITUTE ETHICS COMMITTEE(HUMAN STUDIES)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Physical Health 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Children aged 13-15 years and their parents.
Children using electronic gadgets like mobile phones, lap top, computers, tablets 
 
ExclusionCriteria 
Details  Recent musculoskeletal injury, congenital deformities and any other medical conditions. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Body Mass Index
2.Internet addiction scale
3.Social networking addiction scale
4.Teen Nordic Musculoskeletal screening questionnaire (TNMQ - S) 		 BASELINE  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="121"
Sample Size from India="121" 
Final Enrollment numbers achieved (Total)= "121"
Final Enrollment numbers achieved (India)="121" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/12/2022 
Date of Study Completion (India) 02/05/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rathish@mtpgrihs.ac.in].

  6. For how long will this data be available start date provided 12-12-2022 and end date provided 30-04-2023?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The internet has made a revolution throughout the world of technology and worldwide communication. With the development of economy and technology, the internet is becoming popular. Internet usage has been integrated in day to day life of students for learning and social communication purposes, the internet is also an irreplaceable daily tools for students. 

During the COVID-19 pandemic declared by the World Health organization on 11 March, 2020 the government announced a series of lockdowns. . It has been suggested that the impact of covid-19 lockdown measures on lifestyle behaviors and general well-being of children and adolescents affects larger than that of the infection itself. In terms, of education, there is an increase in the usage of online services during and after lockdown as compared to pre-lockdown as schools, colleges and universities have conducting online classes by using video apps. Extensive use of electronic device has been included as a part of regular schedule. Classes for school and college students are being conducted through online mode. This alternative mode of work involves prolonged screen time exposure. Children and adolescents with obesity are thought to be at even larger risk of lifestyle change and weight gain due to lockdown measures. Hence, the purpose of the study is to evaluate the perception of parents and children regarding increase screen time use and effects on its physical health. Aim:  To explore the association between screen time duration and physical health in children. The school children aged between 13-15 years (7th- 8th standard) who use electronic gadgets along with their parents will be recruited for this study. After collecting informed parental consent form from the parents, assent form from the children and permission letter from the head of the school the study will be conduct in that schools. Both parents and children will be given a standard questionnaire in which it has questions regarding screen time usage duration, height and weight of the children, type of gadgets used and pain status are determined using Teen Nordic Musculoskeletal screening questionnaire (TNMQ - S) mapping. The study which will be conducted in the schools are to estimate the relationship between the screen time exposure and the physical health among the children. To assess the BMI and body proportion changes some details such as height and weight of the children are asked from their parents. Internet addiction scale and Social networking addiction scale are used to find out the relationship between increase screen duration and physical health issues related to the musculoskeletal pain and obesity. Based on the findings advice regarding health education, physical exercise and counselling will be given.  

 
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