NCT05930015

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

July 1, 2023

Last Update Submit

July 1, 2023

Conditions

Keywords

Stress, anxiety and fear of COVID-19

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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.

    week 8

Secondary Outcomes (7)

  • Change from the Athletic Mental Energy Scale (AMES) at week 8

    week 8

  • Change from the Mental Toughness Questionnaire (MTQ) at week 8

    week 8

  • Change from the Portuguese Physical Literacy Assessment Questionnaire (PPLA-Q) at week 8

    week 8

  • Change from the Achievement Emotions Adjective List (AEAL) at week 8

    week 8

  • Saliva cortisol levels

    week 8

  • +2 more secondary outcomes

Study Arms (3)

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.

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.

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.

Behavioral: Music and sports games intervention

Interventions

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

Music 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

Sports games intervention only

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

Music and sports games intervention

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \. Secondary schools' students (both maile and female) in Lanzhou city, years (14-17 years old).
  • \. Able to read and understand the Chinese version questionnaires.
  • \. Understand the information explained by the researcher and agree to be included in the study.
  • \. They are in good health, measured by PAR-Q
  • \. Participants who written consent to participate in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The 200 people tested were randomly divided into 4 groups of 50 each during the intervention phase, with three groups carrying out a intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
student

Study Record Dates

First Submitted

July 1, 2023

First Posted

July 5, 2023

Study Start

October 1, 2022

Primary Completion

December 10, 2022

Study Completion

December 10, 2022

Last Updated

July 5, 2023

Record last verified: 2023-07

Locations