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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)

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ClinicalTrials.gov Identifier: NCT04309097
Recruitment Status : Completed
First Posted : March 16, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Yingfeng Zheng, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Anxiety Digital Eye Strain Behavioral: Digital intervention Behavioral: Information-only intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 954 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Eye Strain and Anxiety Using a Digital Intervention During Online Learning Class Recess Among Children at Home: A Randomized Controlled Trial
Actual Study Start Date : March 16, 2020
Actual Primary Completion Date : March 29, 2020
Actual Study Completion Date : March 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Digital intervention
Participants will have access to a live-streaming App that offers Recess and Exercise Advocate Program (REAP).
Behavioral: 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.


Active Comparator: Information-only intervention
Participants will have access to health information only.
Behavioral: Information-only intervention
Participants will have access to online health information and stay-at-home workout videos.




Primary Outcome Measures :
  1. Change in anxiety [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change in syndromes of digital eye strain [ Time Frame: Baseline & at 2 weeks ]
    Syndromes of digital eye strain will be measured with the Computer Vision Syndrome Questionnaire (CVS-Q) designed by Seguí et al (2015). The self-reported CVS-Q questionnaire (16-item) evaluates the frequency (never, occasionally or often/always) and the intensity (moderate or intense) of 16 symptoms: burning, itching, feeling of a foreign body, tearing, excessive blinking, eye redness, eye pain, heavy eyelids, dryness, blurred vision, double vision, difficulty focusing for near vision, increased sensitivity to light, colored halos around objects, feeling that sight is worsening, and headache. Overall assessment is done by total score.

  2. Change in sleeping quality [ Time Frame: Baseline & at 2 weeks ]
    The PROMIS pediatric sleep disturbance questionnaire (4-item), designed by Forrest et al (2018), assesses self-reported experiences of sleep disturbance over the past 7 days. Raw score will be converted to T-Score.

  3. Changes in time (hour) spent on different near work activities [ Time Frame: Baseline & at 2 weeks ]
    Participants will be asked to indicate the average time in hours per day spent on each the following activities: reading, writing, computer/PAD use, smart phone, watching TV, and playing video games.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04309097


Locations
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China, Guangdong
Secondary schools
Zhaoqing, Guangdong, China, 526000
Sponsors and Collaborators
Sun Yat-sen University
Publications:
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Responsible Party: Yingfeng Zheng, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04309097    
Other Study ID Numbers: 2020KYPJ045
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthenopia
Sprains and Strains
Anxiety Disorders
Mental Disorders
Wounds and Injuries
Eye Diseases