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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)

Primary Purpose

Anxiety, Digital Eye Strain

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Digital intervention
Information-only intervention
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Secondary schools

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital intervention

Information-only intervention

Arm Description

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

Participants will have access to health information only.

Outcomes

Primary Outcome Measures

Change in anxiety
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

Change in syndromes of digital eye strain
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.
Change in sleeping quality
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.
Changes in time (hour) spent on different near work activities
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.

Full Information

First Posted
March 11, 2020
Last Updated
May 10, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04309097
Brief Title
Reducing Eye Strain and Anxiety Using a Digital Intervention During Online Learning Class Recess Among Children at Home: A Randomized Controlled Trial
Acronym
RESILIENT
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 16, 2020 (Actual)
Primary Completion Date
March 29, 2020 (Actual)
Study Completion Date
March 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Digital Eye Strain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
954 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital intervention
Arm Type
Experimental
Arm Description
Participants will have access to a live-streaming App that offers Recess and Exercise Advocate Program (REAP).
Arm Title
Information-only intervention
Arm Type
Active Comparator
Arm Description
Participants will have access to health information only.
Intervention Type
Behavioral
Intervention Name(s)
Digital intervention
Intervention Description
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
Intervention Name(s)
Information-only intervention
Intervention Description
Participants will have access to online health information and stay-at-home workout videos.
Primary Outcome Measure Information:
Title
Change in anxiety
Description
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.
Time Frame
Baseline & at 2 weeks
Secondary Outcome Measure Information:
Title
Change in syndromes of digital eye strain
Description
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.
Time Frame
Baseline & at 2 weeks
Title
Change in sleeping quality
Description
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.
Time Frame
Baseline & at 2 weeks
Title
Changes in time (hour) spent on different near work activities
Description
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.
Time Frame
Baseline & at 2 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Secondary schools
City
Zhaoqing
State/Province
Guangdong
ZIP/Postal Code
526000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32145186
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.
Results Reference
background
PubMed Identifier
25744132
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.
Results Reference
background
PubMed Identifier
29546286
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.
Results Reference
background
PubMed Identifier
9648330
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.
Results Reference
background
PubMed Identifier
33882021
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.
Results Reference
derived

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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

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