Clinical trial NCT04309097: Reducing Eye Strain and Anxiety Using a Digital Intervention During Online Learning Class Recess Among Children at Home: A Randomized Controlled Trial
Official title: Reducing Eye Strain and Anxiety Using a Digital Intervention During Online Learning Class Recess Among Children at Home: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Digital Eye Strain
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 954
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in anxiety
timeFrame: Baseline & at 2 weeks
Secondary outcomes:
measure: Change in syndromes of digital eye strain
timeFrame: Baseline & at 2 weeks
measure: Change in sleeping quality
timeFrame: Baseline & at 2 weeks
measure: Changes in time (hour) spent on different near work activities
timeFrame: Baseline & at 2 weeks
Other outcomes:
Locations:
city: Zhaoqing
country: China
facility: Secondary schools
state: Guangdong
Study officials:
References:
citation: Wang G, Zhang Y, Zhao J, Zhang J, Jiang F. Mitigate the effects of home confinement on children during the COVID-19 outbreak. Lancet. 2020 Mar 21;395(10228):945-947. doi: 10.1016/S0140-6736(20)30547-X. Epub 2020 Mar 4. No abstract available.
citation: Segui Mdel M, Cabrero-Garcia J, Crespo A, Verdu J, Ronda E. A reliable and valid questionnaire was developed to measure computer vision syndrome at the workplace. J Clin Epidemiol. 2015 Jun;68(6):662-73. doi: 10.1016/j.jclinepi.2015.01.015. Epub 2015 Jan 28.
citation: Forrest CB, Meltzer LJ, Marcus CL, de la Motte A, Kratchman A, Buysse DJ, Pilkonis PA, Becker BD, Bevans KB. Development and validation of the PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy054.
citation: Spence SH. A measure of anxiety symptoms among children. Behav Res Ther. 1998 May;36(5):545-66. doi: 10.1016/s0005-7967(98)00034-5.
citation: Zheng Y, Wang W, Zhong Y, Wu F, Zhu Z, Tham YC, Lamoureux E, Xiao L, Zhu E, Liu H, Jin L, Liang L, Luo L, He M, Morgan I, Congdon N, Liu Y. A Peer-to-Peer Live-Streaming Intervention for Children During COVID-19 Homeschooling to Promote Physical Activity and Reduce Anxiety and Eye Strain: Cluster Randomized Controlled Trial. J Med Internet Res. 2021 Apr 30;23(4):e24316. doi: 10.2196/24316.