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临床试验/CTRI/2024/09/073997
CTRI/2024/09/073997尚未招募不适用

Effect of Parental Intervention on Excess Screen Time Usage and Sleep Disorders among 1-5 years of age children - A Hospital based Randomised control study

Yamini1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年9月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
1. to determine the effect of parental screen time education on the excess screen time usage and sleep disorders

研究概览

简要总结

Title of research work: “EFFECT OF PARENTAL INTERVENTION ON EXCESS SCREEN TIME USAGE AND SLEEP DISORDERS AMONG 1- 5 YEARS AGE OF CHILDREN– A HOSPITAL BASED

RANDOMISED CONTROL STUDY”

OBJECTIVES: 1. To determine the correlation between excess screen time usage and sleep score indicating sleep disorder among children of 1-5 years of age. 2. To determine the effect of parental screen time education on the screen time and sleep score after 3 months.

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

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
1.00 Year(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • children 1-5 years of age children whose parents have given consent for the trial.

排除标准

  • children with CNS disorders children who are on antihistamines children with sleep disorders.

结局指标

主要结局

1. to determine the effect of parental screen time education on the excess screen time usage and sleep disorders

时间窗: 3 months

次要结局

  • to determine the correlation between excess screen time usage & sleep score(Outcome after the intervention will me measured after 3 months(12 weeks))

研究者

发起方
Yamini
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Yamini

Sri manakula vinayagar medical college and hospital

研究点 (1)

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