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

NCT ID: NCT04309097

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

954 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-16

Study Completion Date

2020-03-29

Brief Summary

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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

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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.

Conditions

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Anxiety Digital Eye Strain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital intervention

Participants will have access to a live-streaming App that offers Recess and Exercise Advocate Program (REAP).

Group Type EXPERIMENTAL

Digital intervention

Intervention Type BEHAVIORAL

REAP is a live-streaming platform that allows users to shoot short videos or photos related to their physical exercise or eye relaxation (e.g., staring out of the window) using their smartphones. The app has been optimised to be used with the iPhone or Android.

When taking a online course recess, students will have access to the REAP platform that allows them to watch stay-at-home workout videos developed by exercise physiologists. Students will then be asked to create their own workout videos/photos and upload them to the live-streaming platform. When upload is completed, students will receive instant motivational messages to increase their engagement with the program.

Information-only intervention

Participants will have access to health information only.

Group Type ACTIVE_COMPARATOR

Information-only intervention

Intervention Type BEHAVIORAL

Participants will have access to online health information and stay-at-home workout videos.

Interventions

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Digital intervention

REAP is a live-streaming platform that allows users to shoot short videos or photos related to their physical exercise or eye relaxation (e.g., staring out of the window) using their smartphones. The app has been optimised to be used with the iPhone or Android.

When taking a online course recess, students will have access to the REAP platform that allows them to watch stay-at-home workout videos developed by exercise physiologists. Students will then be asked to create their own workout videos/photos and upload them to the live-streaming platform. When upload is completed, students will receive instant motivational messages to increase their engagement with the program.

Intervention Type BEHAVIORAL

Information-only intervention

Participants will have access to online health information and stay-at-home workout videos.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yingfeng Zheng

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Secondary schools

Zhaoqing, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 32145186 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25744132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29546286 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9648330 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33882021 (View on PubMed)

Other Identifiers

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2020KYPJ045

Identifier Type: -

Identifier Source: org_study_id

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