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CTRI Number  CTRI/2024/06/069612 [Registered on: 27/06/2024] Trial Registered Prospectively
Last Modified On: 25/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study on Screen Time and Sleep Quality Among Adolescents in Belagavi City 
Scientific Title of Study   Association of screen time with sleep quality among adolescents between 10-15 years of age from the schools of belagavi city - 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 Punith M S 
Designation  Junior Resident 
Affiliation  KAHERs J.N Medical college, Belagavi 
Address  KAHERs J.N Medical college, Department of Paediatrics, Nehru Nagar, Belagavi - 590010

Belgaum
KARNATAKA
590010
India 
Phone  6362260262  
Fax    
Email  psgowda1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Roopa M Bellad  
Designation  Professor, Department of Paediatrics  
Affiliation  KAHERs J.N Medical college, Belagavi  
Address  KAHERs J.N Medical college, Department of Paediatrics, Nehru Nagar, Belagavi - 590010

Belgaum
KARNATAKA
590010
India 
Phone  9448113403  
Fax    
Email  belladroopa5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Roopa M Bellad  
Designation  Professor, Department of Paediatrics  
Affiliation  KAHERs J.N Medical college, Belagavi  
Address  KAHERs J.N Medical college, Department of Paediatrics, Nehru Nagar, Belagavi - 590010

Belgaum
KARNATAKA
590010
India 
Phone  9448113403  
Fax    
Email  belladroopa5@gmail.com  
 
Source of Monetary or Material Support  
KAHERs J. N Medical college, Nehru Nagar Belagavi - 590010, Karnataka, Indiastate, India.  
 
Primary Sponsor  
Name  KAHERs J N Medical college 
Address  KAHERs J. N Medical college, Nehru Nagar Belagavi 590010 Karnataka state, India 
Type of Sponsor  Private medical college 
 
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 
Dr Punith M S  KLE s Dr. Prabhakar Kore hospital, Nehru Nagar,Belagavi  KAHERs Department of Paediatrics Room number 4 J. N Medical college, Nehru Nagar Belagavi 590010
Belgaum
KARNATAKA 
6362260262

psgowda1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  School going Adolescents between the age of 10 to 15 years 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1) School going adolescents between the age of 10 to 15 years in selected schools of Belagavi city.
2) School going adolescents between the age of 10 to 15 years in selected schools of Belagavi city willing to participate in the study. 
 
ExclusionCriteria 
Details  1) School going adolescents with Absence seizures.
2) School going adolescents with epilepsy disorders.
3) School going adolescents diagnosed with serious health problems.
4) School going adolescents diagnosed with sleeping disorders 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pittsburg Sleep Quality Index (PSQI) questionnaire will be used (16). The questions are divided into seven subcategories, covering subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Additionally, there are five supplementary questions evaluated by the parent/guardian for clinical purposes, and these questions are not given scores. Each question is scored from 0 to 3, and the total scores of the seven components are referred to as the global PSQI score, which ranges from 0 to 21.
PSQI greater than 5 indicates poor sleep quality.
 
To know the association of screen time with sleep quality in school going adolescents between the age group of 10 to 15 years 
 
Secondary Outcome  
Outcome  TimePoints 
The World Health Organization (WHO) characterized physical activity as any bodily movements, produced by skeletal muscles that require energy expenditure. Physical activity refers to all movement including during leisure time, for transport to get to & work from palaces, or as a part of a person’s work.   4 weeks 
 
Target Sample Size   Total Sample Size="664"
Sample Size from India="664" 
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)   08/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  08/07/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="3"
Days="28" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

A rising percentage of adolescents allocate their free time to screens, involving smartphones, tablets gaming consoles and television(1), causing worries among parents, health professionals and educators about the impact of screen time and overall well being. The age at which children regularly interact with screens has fallen from 4 years to 4 months (2). Various studies have shown the hazardous impact of excessive screen use on health. Study conducted across all the countries has showed an average increase of 50 minutes per day since 2013(3). Screen time has increased by 52 percent in adolescents post COVID in India (4). The consumption of YouTube surged during the 2010 Indian Premier League, hitting a daily viewership of over two billion. Predictably, this figure has doubled in each subsequent IPL season. Survey in January 2022 revealed that 13 percent of Indian respondents living in small cities used more than 10 social media platforms(5). 

    Gaming industry has evolved to an unmatchable extent. Excessive use of screens for gaming pursuits has shown lack of physical activity, behavioural problemsdepressive symptoms, including sleep quality in adolescents (6). A statistically noteworthy correlation was identified between aggression and the age and gender of players, particularly prevalent among early adolescent males. Additionally, three studies revealed that, extended durations of video game play significantly correlated with an increased risk of aggression(7). Dopamine, cortisol, serotonin, oxytocin and adrenaline influences the mood and behaviour, especially in adolescent age group. In relation to cortisol, the primary hormone associated with anxiety, it has been observed that video games featuring violent content or those inducing high excitement or fear have a tendency to elevate the levels of cortisol (8). 

       The circadian rhythm of the human sleep-wake cycle is mainly guided by sunlight. Daylight increases alertness, while darkness triggers the production of melatonin, a hormone that promotes sleepiness. Adolescents experiencing insomnia symptoms often have anincreased screen time. Screen usage delays the release of melatonin, prolonging the time to initiate sleep, resulting in less restful overall sleep. Researchers suggest that children and adolescents might be particularly susceptible to the impact of blue light due to their eyesallowing more light exposure (9). 

    Study conducted among the Canadian elementary school children’s physical activity and screen time during the Covid 19 has showed a negative influence on sleep quality and behaviour (10). Various articles and papers are published across India on impact of screen time on physical, mental, social and spiritual health. Many sleep quality research have been conducted in age groups ranging from 5 to 40 years of age. However there are no studieconducted on quality of sleep, development including mental and physical health among the adolescents in India.

 
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