StressNCT05930015
Effects of Music Combined With Sports Games on Alleviating Psychological Stress, Anxiety and Mental Energy Among Adolescents During COVID-19 Pandemic in Lanzhou Gansu Province China
A study testing Music intervention only, Sports games intervention only and Music and sports games intervention in people with Stress and Anxiety and Fear, run by Wu Jiarun at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety and Fear
- What is being tested?
- Music intervention only, Sports games intervention only and Music and sports games intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2022to 10 Dec 2022
- 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 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Music Combined With Sports Games on Alleviating Psychological Stress, Anxiety and Mental Energy Among Adolescents During COVID-19 Pandemic in Lanzhou Gansu Province China (phase2) Research Object 1 To Develop a Music and Sports Games Program for the Secondary School-aged Adolescents. 2 To Examine the Time Effects (Within Groups), Groups Effects (Between Groups) and Interaction Effects (Within-between Groups) of Music and Sports Games on Stress, Anxiety, Mental Energy, Mental Toughness, Self-efficacy and Emotions Among Secondary Schoolaged Adolescents in GanSu Province China.
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.
- Conditions
- Stress, Anxiety and Fear
- Being tested
- Music intervention only, Sports games intervention only, Music and sports games intervention
- Keywords
- Stress, anxiety and fear of COVID-19
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music intervention onlyBehavioural
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 onlyBehavioural
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 interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Music intervention only | Experimental | Music only (the fast tempo of 120-130 bpm music will be selected) The effect was achieved by playing music selected by the researchers during originally physical education classes in school. Receives: Behavioral: Music intervention only |
| Sports games intervention only | Experimental | Sports games intervention only The effect was achieved by replacing the school's originally physical education classes with sports games of the researchers' choice. Receives: Behavioral: Sports games intervention only |
| Music and sports games intervention | Experimental | 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. Receives: Behavioral: Music and sports games intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 8
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 (α =.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.
Measured: week 8
Secondary outcomes (7)
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 α = 0.95) after being used in Taiwan and Malaysia, and proved to be an effective mental energy measurement tool.
Measured: week 8
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.
Measured: week 8
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.
Measured: week 8
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.
Measured: week 8
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.
Measured: week 8
Heart rate variability (HRV)
HRV data were collected using a heart rate variability (HRV) analyser.
Measured: week 8
Blood oxygen saturation (SaO2)
Blood oxygen saturation (SaO2) data were collected using an oxygen saturation tester.
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Oct 2022
- Primary completion10 Dec 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- The 200 people tested were randomly divided into 4 groups of 50 each during the intervention phase, with three groups carrying out a intervention
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wu Jiarun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wu Jiarun, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930015
- Sponsor's protocol ID
- WJiarun
- Status last verified
- Jul 2023
- First submitted
- 1 Jul 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music Combined With Sports Games on Alleviating Psychological Stress, Anxiety and Mental Energy Among Adolescents During COVID-19 Pandemic in Lanzhou Gansu Province China (phase2) Research Object 1 To Develop a Music and Sports Games Program for the Secondary School-aged Adolescents. 2 To Examine the Time Effects (Within Groups), Groups Effects (Between Groups) and Interaction Effects (Within-between Groups) of Music and Sports Games on Stress, Anxiety, Mental Energy, Mental Toughness, Self-efficacy and Emotions Among Secondary Schoolaged Adolescents in GanSu Province China.
- ClinicalTrials.gov ID
- NCT05930015
- Acronym / sponsor ID
- WJiarun
- Conditions
- Stress, Anxiety and Fear
- Keywords
- Stress, anxiety and fear of COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Wu JiarunUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 10 Dec 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The 200 people tested were randomly divided into 4 groups of 50 each during the intervention phase, with three groups carrying out a intervention
| Arm | Type | Receives |
|---|---|---|
| Music intervention only | Experimental | Behavioral: Music intervention onlyMusic only (the fast tempo of 120-130 bpm music will be selected) The effect was achieved by playing music selected by the researchers during originally physical education classes in school. |
| Sports games intervention only | Experimental | Behavioral: Sports games intervention onlySports games intervention only The effect was achieved by replacing the school's originally physical education classes with sports games of the researchers' choice. |
| Music and sports games intervention | Experimental | Behavioral: Music and sports games interventionMusic 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music intervention onlyMusic 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 | Behavioural | Music intervention only |
| Sports games intervention onlySports 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 | Behavioural | Sports games intervention only |
| Music and sports games interventionMusic 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 | Behavioural | Music and sports games intervention |
Primary outcome
Change from the Stress and anxiety to viral epidemics-6 (SAVE-6) at week 8
Time frame: 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.
Change from the Fear of COVID-19 scale (FCV-19) at week 8
Time frame: 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 (α =.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.
7 secondary outcomes
Change from the Athletic Mental Energy Scale (AMES) at week 8
Time frame: week 8
Change from the Mental Toughness Questionnaire (MTQ) at week 8
Time frame: week 8
Change from the Portuguese Physical Literacy Assessment Questionnaire (PPLA-Q) at week 8
Time frame: week 8
Change from the Achievement Emotions Adjective List (AEAL) at week 8
Time frame: week 8
Saliva cortisol levels
Time frame: week 8
Heart rate variability (HRV)
Time frame: week 8
Blood oxygen saturation (SaO2)
Time frame: week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention only, Sports games intervention only and Music and sports games intervention in people with Stress and Anxiety and Fear, run by Wu Jiarun at 1 site in Malaysia.
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 5 inclusion and 1 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 5 Jul 2023. 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 Malaysia. 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 from the Stress and anxiety to viral epidemics-6 (SAVE-6) at week 8 (time frame: week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.