Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001528741p
Ethics application status
Submitted, not yet approved
Date submitted
1/12/2022
Date registered
12/12/2022
Date last updated
12/12/2022
Date data sharing statement initially provided
12/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the cultural context impact on mood and stress level? A quasi-experimental pilot study on traditional Chinese medicine five-phase music therapy
Scientific title
Does the cultural context impact on mood and stress level? A quasi-experimental pilot study on traditional Chinese medicine five-phase music therapy in those identified to have Liver Qi Stagnation, a specific traditional Chinese medicine pattern
Secondary ID [1] 308508 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
individuals with a specific traditional Chinese medicine pattern (Liver Qi Stagnation pattern) 328329 0
low mood 328330 0
Stress 328427 0
Condition category
Condition code
Alternative and Complementary Medicine 325368 325368 0 0
Other alternative and complementary medicine
Mental Health 325450 325450 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention received by the two study groups will be the same. Traditional Chinese medicine five-phase music intervention will be conducted in the two study groups. Five-phase music is composed using the model of five phases (Earth, Metal, Wood, Fire, and Water), which correspond with five music scales - Gong (do), Shang (re), Jue (mi), Zhi (so), Yu (la) respectively. In this study, the Yin-rhythm Wood-phase music piece of the CD “Traditional Chinese Medicine Health Tianyun Five Elements Music” published by Beijing Higher Education Audio-Visual Press is selected as the intervention. The music is located in the platform bilibili (Link: https://www.bilibili.com/video/BV1kP4y1N7RA?spm_id_from=333.337.search-card.all.click ). The length of the music is 25 minutes. It is a one-time online intervention.

The participants are required to listen to the music in a quiet, clean, warm and relaxing indoor environment with good ventilation. Throughout the 25 minutes of the audio intervention, the participants are instructed to stay on the intervention page unless they feel unwell or experience any other emergencies. They are instructed to adjust the music to a volume that they feel comfortable with. The participants can listen to the music by using the speakers or headphones. If participants stay in a room alone, they are asked to close the door to keep the room quiet and avoid disruptions from outside. They are required to listen to music alone without any interactions with other people and not to engage other activities during the 25 minutes audio intervention. Participants are required to pay full attention during the audio intervention and maintain a steady breathing rate. Participants will be asked to complete a survey regarding the music intervention afterwards, which is an indication that they have completed the audio intervention.
Intervention code [1] 324949 0
Treatment: Other
Comparator / control treatment
The intervention received by the two study groups will be the same. The difference between the two study groups is the cultural background of the participants. The Active cultural group will involve participants who are familiar with Chinese culture while the Inactive cultural group will include participants who are not familiar with Chinese culture. They will receive the same music intervention.
Control group
Active

Outcomes
Primary outcome [1] 333251 0
The change of mood state, measured by the short form of Profile of mood states questionnaire (POMS-SF)
Timepoint [1] 333251 0
This will be measured just before and just after the intervention.
Primary outcome [2] 333254 0
The change of stress level, assessed by The Perceived Stress Scale (PSS)
Timepoint [2] 333254 0
This will be measured just before and just after the intervention.
Secondary outcome [1] 416354 0
The change of severity of Liver Qi stagnation, measured by the questionnaire for diagnosis of Qi Stagnation (QDQS)
Timepoint [1] 416354 0
This will be measured before and just after the intervention.
Secondary outcome [2] 416380 0
The familiarity of the music piece played in the intervention, assessed by the Exit survey
The Exit survey is designed for this study.
Timepoint [2] 416380 0
This will be measured just after the intervention.
Secondary outcome [3] 416574 0
The enjoyment of the music piece played in the intervention, assessed by the Exit survey
The Exit survey is designed for this study.
Timepoint [3] 416574 0
This will be measured just after the intervention.
Secondary outcome [4] 416575 0
The familiarity of five-phase music therapy, assessed by the Exit survey
The Exit survey is designed for this study.
Timepoint [4] 416575 0
This will be measured just after the intervention.
Secondary outcome [5] 416576 0
Whether the participants undertake the intervention for once or not, assessed by the Exit survey
The Exit survey is designed for this study.
Timepoint [5] 416576 0
This will be measured just after the intervention.

Eligibility
Key inclusion criteria
Participants will be included if they satisfy all the following criteria. If they signed the consent form, can understand English, have adequate visual and auditory acuity to perform the study tasks, and are classified as Qi Stagnation pattern according to the questionnaire for diagnosis of Qi Stagnation (QDQS), they are eligible for the study.
In addition to the above criteria, they have to be raised in a Chinese language environment and can understand (can listen, speak, read and write) Chinese (Chinese means Cantonese, Mandarin or Chinese dialects) to be eligible to be included in Active cultural group. On the other hand, if they were not raised in a Chinese language environment and cannot understand Chinese, they are eligible to be included in Inactive cultural group,
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have medical condition(s), such as uncorrected hearing disabilities, that affect(s) music listening. They will also be excluded if they are receiving Chinese medicine five-phase music therapy in other settings.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The Active cultural group will involve participants who are familiar with Chinese culture while the Inactive cultural group will include participants who are not familiar with Chinese culture. They will receive the same music intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study to explore if cultural context will impact on the influence of five-phase music therapy (FMT) on mood and stress level. As there is no existing FMT-related studies exploring similar issues, a sample size calculation was not conducted. This study will serve as a reference for the sample size calculation of future full-scale studies with similar topics.
The recommended sample size for a pilot study is 12 people per study group. The sample size of the study will be 24 people. As the expected attrition rate is 20%, a total of 30 people will be recruited, with 15 people in each group.
For the data analysis process, the IBM SPSS software will be used to perform the data analysis. Intention-to-treat analysis will be employed to compare the outcomes of the two groups. The impact of the intervention on the two study groups will be compared based on the primary outcomes. The primary measures are the change of mood state and the change of stress level before and after the intervention.
Descriptive statistics will be provided for all normally distributed variables in the form of mean scores and standard deviations before and after the intervention on each of the outcome measurement tools. The variables that are not normally distributed will be represented as median scores and ranges. Differences in scores on every dependent variable are measured before and after the intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/01/2023
Actual
Date of last participant enrolment
Anticipated
16/02/2023
Actual
Date of last data collection
Anticipated
16/02/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312779 0
University
Name [1] 312779 0
Western Sydney University
Country [1] 312779 0
Australia
Primary sponsor type
Individual
Name
Wing Yu Yu
Address
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 314460 0
Individual
Name [1] 314460 0
Yu-Ting Sun
Address [1] 314460 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country [1] 314460 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312052 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 312052 0
Ethics committee country [1] 312052 0
Australia
Date submitted for ethics approval [1] 312052 0
04/10/2022
Approval date [1] 312052 0
Ethics approval number [1] 312052 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123286 0
Miss Wing Yu Yu
Address 123286 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country 123286 0
Australia
Phone 123286 0
+61 2 4620 3795
Fax 123286 0
Email 123286 0
[email protected]
Contact person for public queries
Name 123287 0
Wing Yu Yu
Address 123287 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country 123287 0
Australia
Phone 123287 0
+61 2 4620 3795
Fax 123287 0
Email 123287 0
[email protected]
Contact person for scientific queries
Name 123288 0
Wing Yu Yu
Address 123288 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country 123288 0
Australia
Phone 123288 0
+61 2 4620 3795
Fax 123288 0
Email 123288 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Only to achieve the aims in the approved proposal and for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Wing Yu Yu, email: [email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.