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

Sun Yat-sen University logo

Sun Yat-sen University

Status

Completed

Conditions

Digital Eye Strain
Anxiety

Treatments

Behavioral: Information-only intervention
Behavioral: Digital intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04309097
2020KYPJ045

Details and patient eligibility

About

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.

Full 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.

Enrollment

954 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

954 participants in 2 patient groups

Digital intervention
Experimental group
Description:
Participants will have access to a live-streaming App that offers Recess and Exercise Advocate Program (REAP).
Treatment:
Behavioral: Digital intervention
Information-only intervention
Active Comparator group
Description:
Participants will have access to health information only.
Treatment:
Behavioral: Information-only intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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