CTRI

SETTING:
This study will be done under the Department of Paediatrics in Sri Manakula Vinayagar Medical College
and Hospital (SMVMCH), Puducherry.
STUDY DESIGN:
The proposed study will be a hospital based randomised control study.
STUDY PARTICIPANTS:
Children of aged 1 to 5 years attending the Paediatric OPD will be included for the study purpose.
INCLUSION CRITERIA:
Children aged 1 to 5 years with excess screen time whose parents have given consent
EXCLUSION CRITERIA:
ï‚· Participants whose parent did not give written consent
ï‚· Children with known neurological disorders like microcephaly, neurodevelopmental delay and other
syndromic diseases, known neuropsychiatric disorders, known sleep disorders.
ï‚· Children on sedative drugs like antihistamines.
STUDY DURATION:
The data collection will be done for a period of 18 months from the date of approval of the present study.

SAMPLE SIZE: Based on the mean difference{0.84) between treatment group(2.05) and control group in a(1.21)
study by Breter O F et al, the sample size for the present study was calculated to be 150 with 75 in each group at
95% confidence interval and 5%absolute precision.. The sample size is calculated using OpenEpi, version 3.
SAMPLING METHOD: Children in the age group of 1-5 years presenting with excess screen time usage are
recruited from the Paediatrics OPD at Sri Manakula Vinayagar Medical College And Hospital fulfilling inclusion
criteria will be considered for study by continuous sampling method till the required number of study participants
are achieved
DATA COLLECTION:
Drawing up a protocol: According to IAP guidelines. For children of less than 2 years should not be exposed to
any type of screen and children 24-59 months, limiting screen time to a maximum of 1 hour per day.
Selection reference and experimental population: Children 1-5 years of age having excess screen time and
given consent from parents by continuous random sampling method (n=150)

Sleep score is assessed using the children sleep habits questionnaire(CSHQ)

Randomization:an online source(www.sealedenvelope.com) will be used to allocation of study subjects (children
in the age of 1-5 years with excess screen time)into two groups by computer generated method.the two study
groups are group A(single time intervention with parental education) and the group B( single time intervention
with parental education with positive reinforcement)

Blinding: Single blinded study(participants only)

Single time intervention by parental health Single time intervention by parental education method
education method (75 participants) with positive reinforcement at monthly intervals (75 participants in each)

Followup: The sleep score is assessed for both the groups at the end of 3 months

Analysis: Results between the two types of intervention groups is interpreted and end result is calculated by chi-
square for test of significance and correlation between excess screen time and sleep score is assessed