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AnxietyRESILIENTNCT04309097

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

A study testing Digital intervention and Information-only intervention in people with Anxiety and Digital Eye Strain, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Anxiety, Digital Eye Strain
What is being tested?
Digital intervention and Information-only intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
954 participants
Where
1 siteChina
Study dates
16 Mar 2020to 29 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

China1 site

  • Secondary schools

    Zhaoqing, Guangdong, 526000

Other trials in China

About this study

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.

Read the 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.

Being tested
Digital intervention, Information-only intervention
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital interventionBehavioural

    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 interventionBehavioural

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

Study groups in NCT04309097
Study groupRoleWhat they receive
Digital interventionExperimentalParticipants will have access to a live-streaming App that offers Recess and Exercise Advocate Program (REAP).
Receives: Behavioral: Digital intervention
Information-only interventionActive comparatorParticipants will have access to health information only.
Receives: Behavioral: Information-only intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline & at 2 weeks

Secondary outcomes (3)

  1. 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.

    Measured: Baseline & at 2 weeks

  2. 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.

    Measured: Baseline & at 2 weeks

  3. 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.

    Measured: Baseline & at 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2020
  2. Study start16 Mar 2020
  3. Primary completion29 Mar 2020
  4. Study completion29 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
954 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04309097
Sponsor's protocol ID
2020KYPJ045
Acronym
RESILIENT
Status last verified
May 2020
First submitted
11 Mar 2020
Last updated
12 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32145186

  • 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.

    PubMed 25744132

  • 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.

    PubMed 29546286

  • 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.

    PubMed 9648330

  • 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.

    PubMed 33882021

Questions about this trial

What is this clinical trial studying?

A study testing Digital intervention and Information-only intervention in people with Anxiety and Digital Eye Strain, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in anxiety (time frame: Baseline & at 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04309097, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.

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RESILIENT Clinical Trial NCT04309097 | AzTrials