| CTRI Number |
CTRI/2024/09/074264 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Longitudinal Study on Effect Frequent Smart Phone Usage on Quality of Sleep and Mental Health among mothers of Primary School Children |
|
Scientific Title of Study
|
A Longitudinal Study on Effect Frequent Smart Phone Usage on Quality of Sleep and Mental Health among mothers of Primary School Children, Nellore, A.P in a view to develop awareness pamphlet |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thejovathi G |
| Designation |
Associate Professor, Child Health Nursing Department |
| Affiliation |
Narayana College of Nursing, Dr.NTR.University of Health Sciences |
| Address |
Child health Nursing Department, 4th floor.
Narayana Medical College and hospital
staff quarters 49
Chinthareddypalem Nellore
pin 524003
W/o D.Kumar
Door No: 3-146-10A, Tella Gutta palli, kalikiri,
ANdhra Pradesh-517234
Chittoor
ANDHRA PRADESH
524003
India |
| Phone |
9182385535 |
| Fax |
|
| Email |
tejaswani.987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Kantha |
| Designation |
Professor, Department of Community Health Nursing |
| Affiliation |
Narayana College of Nursing |
| Address |
member Secretary of IEC of Narayana College of Nursing
1st floor Narayana College of Nursing Nursing
House No: 24, Staff Quarters,
Narayana Medical College & Hospital, Chinthareddypalem, Nellore.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9441633279 |
| Fax |
|
| Email |
kanthanaren@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vanaja Kumari |
| Designation |
Principal |
| Affiliation |
Narayana College of Nursing |
| Address |
HOD of Community Health Nursing Department
Staff Quarters, Narayana Medical college campus, chinthareddy palem, Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9949691567 |
| Fax |
|
| Email |
bnreddy290@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr YSR university of health Sciences, ring Near Siddhartha Medical College, Beside New Government General Hospital, near Ramavarappadu, Vijayawada, Andhra Pradesh 520008Vijayawada |
|
|
Primary Sponsor
|
| Name |
Dr YSR university of health sciences |
| Address |
Dr YSR University of health Sciences
NH 16 Service Road
Gunadala Vijayawada
Andhra Pradesh 520008 |
| Type of Sponsor |
Other [Narayana College of Nursing ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Narayana College of Nursing |
Narayana Medical college campus, Chinthareddypalem, Nellore- 524002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr LathaA |
Narayana medical college and hospital |
Pediatric ward, 2nd floor
Narayana General Hospital
Nellore
ANDHRA PRADESH |
9160887339
0862317969
manavalanlatha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Narayana College of Nursing |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary School Children to assess the effect of frequent use of smart phones on metal health |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
it is observational study to assess the effect of frequent smart phone usage on quality of sleep and mental health |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
both genders
willing to participant
who has smart phone and habit to use foe prolog time
selected areas |
|
| ExclusionCriteria |
| Details |
1. Child Suffering with sensory deprivation, insomnia, mental illness and Juvenile diabetes.
2. Children with serious developmental disabilities, such as autism or intellectual disability.
3. Any known medical conditions that could lead to neck or back pain and pre-diagnosed mental health.
4. Habit of using Basic phone.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Monitoring the development or exacerbation of anxiety and depressive symptoms in relation to smartphone use.
Assessing potential impacts on attention span, memory, and cognitive development.
Sleep Quality: Evaluating changes in sleep patterns and quality, including the onset of sleep disorders. |
Monitoring the development or exacerbation of anxiety and depressive symptoms in relation to smartphone use.
Assessing potential impacts on attention span, memory, and cognitive development.
Sleep Quality: Evaluating changes in sleep patterns and quality, including the onset of sleep disorders.
observing every 4 months once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
assess parents knowledge how to avoid usage of smart phones in children and among them.
assess knowledge the effect of smart phone on children so that can modify parents bahaviour |
4 months once |
|
|
Target Sample Size
|
Total Sample Size="380"
Sample Size from India="380"
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)
|
21/10/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This longitudinal study investigated the impact of frequent smartphone usage on the quality of sleep and mental health of primary school children in Nellore, Andhra Pradesh. The study involved a sample of 380 children selected from various areas in Nellore. Over a defined period, researchers monitored the children’s smartphone usage patterns, sleep quality, and mental health indicators such as anxiety, stress, and mood disorders. Key findings highlighted a significant correlation between high smartphone usage and poor sleep quality, including difficulties in falling asleep, reduced sleep duration, and increased daytime sleepiness. Additionally, children who frequently used smartphones showed higher levels of anxiety and stress, with some exhibiting early signs of depressive symptoms. Based on these findings, the study aimed to develop an awareness pamphlet to educate parents, teachers, and children about the potential risks of excessive smartphone use and provide tips for promoting healthier usage habits to protect sleep quality and mental well-being. |