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临床试验/NCT04309097
NCT04309097已完成不适用

Reducing Eye Strain and Anxiety Using a Digital Intervention During Online Learning Class Recess Among Children at Home: A Randomized Controlled Trial

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 954 人开始时间: 2020年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
954
试验地点
1
主要终点
Change in anxiety

研究概览

简要总结

The primary aim of the current study is to conduct a cluster-randomized control trial to evaluate the effectiveness of a novel digital intervention in reducing anxiety and digital eye strain compared to usual care among Chinese children during the period of home confinement.

详细描述

In response to the coronavirus disease 2019 (COVID-19), many countries have taken the decision of school closure after the confirmation of coronavirus cases in the general population. In China, the burden of COVID-19 is among the highest in the world, with more than 80,000 cases confirmed by 11th March 2020. An estimate of 220 million children and adolescents are confined at home for weeks with inadequate level of physical activity and more susceptible to anxiety. There is also a concern of digital eye strain for many children who spend hours daily in front of a computer screen for recreation or learning purposes.

Recess represents an essential scheduled period in a school day for psychological and physical relaxation. During the unusual period of home confinement, many schools have already issued physical activity requirement and policy recommending recess and physical activity breaks. However, recess could be easily skipped by students during online learning at home.

Mobile health intervention offers a potential opportunity for capitalizing on digital technology as a feasible modality to encourage recess activities, especially in regions where social distancing is implemented as an emergency measure. The primary aim of the current study is to conduct a cluster-randomized control trial to evaluate the effectiveness of a novel digital intervention during recess in reducing anxiety and digital eye strain compared to usual care among Chinese children during the period of home confinement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Grade 7 (12-13 years old) students in Duanzhou District, Zhaoqing city
  • Students under home confinement and enrolled in online learning courses, during the COVID-19 outbreak

排除标准

  • Autism Spectrum Disorders and Pervasive Developmental Delay or Disorder
  • Mental Retardation
  • Psychotic Disorders and Schizophrenia
  • Mania or Hypomania disorders
  • Suicidal behavior and/or acute plan that require higher level of care
  • Participation in psychotherapy

结局指标

主要结局

Change in anxiety

时间窗: Baseline & at 2 weeks

Change in anxiety will be measured by the Spence Children's Anxiety Scale (SCAS) designed by Spence (1998). The SCAS (45-item) is self-report scale with a 4-point Likert type, consisting of 44 items and one open-ended question. Overall assessment is done by total score.

次要结局

  • Change in syndromes of digital eye strain(Baseline & at 2 weeks)
  • Change in sleeping quality(Baseline & at 2 weeks)
  • Changes in time (hour) spent on different near work activities(Baseline & at 2 weeks)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yingfeng Zheng

Professor

Sun Yat-sen University

研究点 (1)

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