| 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
|
|
|
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
|
|
|
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 problems, depressive 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 studies conducted on quality of sleep, development including mental and physical health among the adolescents in India. |