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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

Primary Purpose

Stress, Anxiety and Fear

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Music intervention only
Sports games intervention only
Music and sports games intervention
Sponsored by
Wu Jiarun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring Stress, anxiety and fear of COVID-19

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universiti Sains Malaysia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Music intervention only

Sports games intervention only

Music and sports games intervention

Arm Description

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.

Sports 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, 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Heart rate variability (HRV)
HRV data were collected using a heart rate variability (HRV) analyser.
Blood oxygen saturation (SaO2)
Blood oxygen saturation (SaO2) data were collected using an oxygen saturation tester.

Full Information

First Posted
July 1, 2023
Last Updated
July 1, 2023
Sponsor
Wu Jiarun
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1. Study Identification

Unique Protocol Identification Number
NCT05930015
Brief 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
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 10, 2022 (Actual)
Study Completion Date
December 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wu Jiarun

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anxiety and Fear
Keywords
Stress, anxiety and fear of COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music intervention only
Arm Type
Experimental
Arm Description
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.
Arm Title
Sports games intervention only
Arm Type
Experimental
Arm Description
Sports games intervention only The effect was achieved by replacing the school's originally physical education classes with sports games of the researchers' choice.
Arm Title
Music and sports games intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Music intervention only
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Sports games intervention only
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Music and sports games intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from the Stress and anxiety to viral epidemics-6 (SAVE-6) at week 8
Description
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.
Time Frame
week 8
Title
Change from the Fear of COVID-19 scale (FCV-19) at week 8
Description
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.
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Change from the Athletic Mental Energy Scale (AMES) at week 8
Description
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.
Time Frame
week 8
Title
Change from the Mental Toughness Questionnaire (MTQ) at week 8
Description
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.
Time Frame
week 8
Title
Change from the Portuguese Physical Literacy Assessment Questionnaire (PPLA-Q) at week 8
Description
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.
Time Frame
week 8
Title
Change from the Achievement Emotions Adjective List (AEAL) at week 8
Description
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.
Time Frame
week 8
Title
Saliva cortisol levels
Description
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.
Time Frame
week 8
Title
Heart rate variability (HRV)
Description
HRV data were collected using a heart rate variability (HRV) analyser.
Time Frame
week 8
Title
Blood oxygen saturation (SaO2)
Description
Blood oxygen saturation (SaO2) data were collected using an oxygen saturation tester.
Time Frame
week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Universiti Sains Malaysia
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia

12. IPD Sharing Statement

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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

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