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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05930015
Other study ID # WJiarun
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date December 10, 2022

Study information

Verified date July 2023
Source Universiti Sains Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this observational study was to assess whether music and sports play interventions were effective in reducing stress, anxiety and fear of COVID-19 among secondary school students in Gansu Province; The effects of music, sports games, and music combined with sports games were compared.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 10, 2022
Est. primary completion date December 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 17 Years
Eligibility Inclusion Criteria: - 1. Secondary schools' students (both maile and female) in Lanzhou city, years (14-17 years old). - 2. Able to read and understand the Chinese version questionnaires. - 3. Understand the information explained by the researcher and agree to be included in the study. - 4. They are in good health, measured by PAR-Q - 5. Participants who written consent to participate in the study. Exclusion Criteria: - Participants with disabilities that prevent them from physically active. Also, those who withdraw in the middle or at the end of the intervention before answering the questionnaire of post-trial.

Study Design


Intervention

Behavioral:
Music intervention only
Music only (120-130 bpm) The effect was achieved by playing music selected by the researchers during originally physical education classes in school; twice a week for eight weeks
Sports games intervention only
Sports games intervention only The effect was achieved by replacing the school's originally physical education classes with sports games of the researchers' choice; twice a week for eight weeks
Music and sports games intervention
Music and sports games intervention, the effect was achieved by replacing the school's physical education classes with sports games of the researchers' choice, and then by playing music of the researchers' choice during class; twice a week for eight weeks

Locations

Country Name City State
Malaysia Universiti Sains Malaysia Kota Bharu Kelantan

Sponsors (1)

Lead Sponsor Collaborator
Wu Jiarun

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from the Stress and anxiety to viral epidemics-6 (SAVE-6) at week 8 Save-6 is a questionnaire developed by South Korean scholars Chung et al. (2021) in 2021 to measure the stress and anxiety responses of ordinary residents to COVID-19. The questionnaire contains six questions, including six major symptoms of stress and anxiety in the general public in response to COVID-19. The save-6 scale obtained good internal consistency after use in Korea (Cronbach's Alpha = 0.815). The Save-6 scale was found to be a reliable, valid and useful simple measurement that could be applied to the general population. week 8
Primary Change from the Fear of COVID-19 scale (FCV-19) at week 8 The Fear of Coronavirus Scale is a questionnaire designed to measure the Fear, concern and anxiety of the general public regarding COVID-19. It was developed by Ahorsu et al. (2020) research and development. The questionnaire includes seven items of public fear of COVID-19 (item-total correlation (0.47 to 0.56)). More specifically, Reliability values such as internal consistency (a =.82) and test -- retest reliability (ICC =.72) were acceptable. The Fear of COVID-19 Scale, a seven-item scale, has robust psychometric properties. It is reliable and valid in assessing fear of COVID-19 among the general population and will also be useful in allaying COVID-19 fears among individuals. week 8
Secondary Change from the Athletic Mental Energy Scale (AMES) at week 8 Athletic Mental Energy Scale (AMES) is a questionnaire developed by Lu et al. (2018) which is specially used to measure Mental Energy. The questionnaire consists of 18 related questions. The test subjects need to choose the most consistent level from the six feelings (completely so - completely not) according to their feelings, and each feeling has corresponding score (6-1). The final score can represent the mental energy of the subject. The questionnaire obtained high reliability (Cronbach's a = 0.95) after being used in Taiwan and Malaysia, and proved to be an effective mental energy measurement tool. week 8
Secondary Change from the Mental Toughness Questionnaire (MTQ) at week 8 Clough et al. (2002) developed a measure of mental toughness known as the Mental Toughness Questionnaire-48 (MTQ-48). The questionnaire contains 48 questions about mental toughness. Participants were asked to choose the most consistent of five feelings (strongly disagree - strongly agree) based on how they felt, with each feeling given a score (1-5). The final score represents the participants' mental toughness. The questionnaire has been widely used to measure mental toughness and is an effective measurement tool. week 8
Secondary Change from the Portuguese Physical Literacy Assessment Questionnaire (PPLA-Q) at week 8 Portuguese Physical Literacy Assessment Questionnaire (PPLA-Q) is a survey published by Mota et al. (2021). The developed questionnaire is designed to measure the physical literacy of high school students. The questionnaire contains three modules of cognitive, psychology and social. In this study, we choose the module of psychological (46 likert-type items). Participants were asked to choose the most consistent of five feelings (not at all - totally) based on how they felt, with each feeling given a score (0-4). The final score represents the participants' Physical literacy. The questionnaire has been used to measure middle school students in Portugal and is an effective measurement tool. week 8
Secondary Change from the Achievement Emotions Adjective List (AEAL) at week 8 The Achievement Emotions Adjective List (AEAL) is a brief self-report multi-item questionnaire deputed to assess ten achievement emotions, namely enjoyment, pride, hope, relief, relaxation, anxiety, anger, shame, hopelessness, and boredom. The AEAL is a questionnaire developed by Raccanello et al. (2021) and it scale achieved good internal consistency after use in Switzerland's middle school students (Cronbach's Alpha = 0.78). AEAL is considered to be a simple, non-invasive and effective tool for assessing the emotions of middle school students. week 8
Secondary Saliva cortisol levels Saliva cortisol levels should be measured according to the tools and methods required by local medical institutions. Saliva of some subjects should be collected and handed over to local medical institutions for relevant measurement. week 8
Secondary Heart rate variability (HRV) HRV data were collected using a heart rate variability (HRV) analyser. week 8
Secondary Blood oxygen saturation (SaO2) Blood oxygen saturation (SaO2) data were collected using an oxygen saturation tester. week 8
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