Reducing Eye Strain and Anxiety Using a Digital Intervention During Online Learning Class Recess Among Children at Home: A Randomized Controlled Trial
RESILIENT
1 other identifier
interventional
954
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable anxiety
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2020
CompletedFirst Posted
Study publicly available on registry
March 16, 2020
CompletedStudy Start
First participant enrolled
March 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2020
CompletedMay 12, 2020
May 1, 2020
13 days
March 11, 2020
May 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline & at 2 weeks
Secondary Outcomes (3)
Change in syndromes of digital eye strain
Baseline & at 2 weeks
Change in sleeping quality
Baseline & at 2 weeks
Changes in time (hour) spent on different near work activities
Baseline & at 2 weeks
Study Arms (2)
Digital intervention
EXPERIMENTALParticipants will have access to a live-streaming App that offers Recess and Exercise Advocate Program (REAP).
Information-only intervention
ACTIVE COMPARATORParticipants will have access to health information only.
Interventions
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.
Participants will have access to online health information and stay-at-home workout videos.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Secondary schools
Zhaoqing, Guangdong, 526000, China
Related Publications (5)
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.
PMID: 32145186BACKGROUNDSegui 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.
PMID: 25744132BACKGROUNDForrest 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.
PMID: 29546286BACKGROUNDSpence 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.
PMID: 9648330BACKGROUNDZheng 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.
PMID: 33882021DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 11, 2020
First Posted
March 16, 2020
Study Start
March 16, 2020
Primary Completion
March 29, 2020
Study Completion
March 29, 2020
Last Updated
May 12, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share