Anxiety Clinical Trial
— RESILIENTOfficial title:
Reducing Eye Strain and Anxiety Using a Digital Intervention During Online Learning Class Recess Among Children at Home: A Randomized Controlled Trial
Verified date | May 2020 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 954 |
Est. completion date | March 29, 2020 |
Est. primary completion date | March 29, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Secondary schools | Zhaoqing | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
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. — View Citation
Seguí Mdel M, Cabrero-García J, Crespo A, Verdú 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. — View Citation
Spence SH. A measure of anxiety symptoms among children. Behav Res Ther. 1998 May;36(5):545-66. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 SeguĂ 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. | Baseline & at 2 weeks | |
Secondary | 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. | Baseline & at 2 weeks | |
Secondary | 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. | Baseline & at 2 weeks |
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