Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000960651
Ethics application status
Approved
Date submitted
2/07/2023
Date registered
4/09/2023
Date last updated
6/11/2023
Date data sharing statement initially provided
4/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of binaural beats in Chinese instrumental music on psychological and physical well-being among older adults.
Scientific title
Effectiveness of binaural beats in Chinese instrumental music on psychological and physical well-being among older adults.
Secondary ID [1] 310023 0
Singapore Institute of Technology (SIT) Project ID: 2022098
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 330554 0
Mood 330555 0
Stress 330556 0
Chronic pain 330557 0
Condition category
Condition code
Mental Health 327394 327394 0 0
Anxiety
Mental Health 327395 327395 0 0
Depression
Mental Health 327396 327396 0 0
Studies of normal psychology, cognitive function and behaviour
Musculoskeletal 327397 327397 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a 30-minute audio file containing Chinese instrumental music with Binaural Beats (Theta progressing to Delta Binaural Beats) that has been specially designed for this study. Participants will sit in a quiet room set up by the researchers and listen to the audio file on a laptop through headphones connected via a 3.5mm headphone adaptor once only. Researchers will be seated in the same room as the participants throughout the intervention to ensure fidelity.
Intervention code [1] 326444 0
Treatment: Other
Comparator / control treatment
The control will be a 30-minute audio file containing Chinese instrumental music without Binaural Beats that has been specially designed for this study.
Control group
Active

Outcomes
Primary outcome [1] 335267 0
Change in State-trait Anxiety Inventory (STAI) Y1 score.
Timepoint [1] 335267 0
Baseline, immediately post-intervention.
Primary outcome [2] 335268 0
Change in Profile of Mood States (35-items) score.
Timepoint [2] 335268 0
Baseline, immediately post-intervention.
Primary outcome [3] 335269 0
Change in Perceived Stress Scale (15-items) score.
Timepoint [3] 335269 0
Baseline, immediately post-intervention.
Secondary outcome [1] 423662 0
Change in Visual Analogue Scale (for Chronic pain) score.
Timepoint [1] 423662 0
Baseline, immediately post-intervention.

Eligibility
Key inclusion criteria
The inclusion criteria include participants who are 60 years old and above with self-reported chronic pain for over 3 months.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria are: (1) cognitive impairment (Abbreviated Mental Test score less than or equal to 6), (2) profound hearing loss, (3) official diagnosis of mental disorders, (4) acute injuries in the past 3 months and (5) unable to understand/ converse in English, Mandarin and/or Chinese dialects.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation: Excel sheet with randomly generated numbers of either '1' or '2's. The '1' and '2' represent audio file 'A' and 'B' respectively, one of which will contain the intervention and the other will contain the control.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
100 participants will be recruited. The sample size calculation was determined using G*Power based on the analysis of variance (ANOVA). The parameters used for the sample size calculation were effect size equal to 0.15, alpha value equal to 0.05, statistical power equal to 0.80, number of groups equal to 2, number of measurements equal to 2 times. The estimated sample size was 45 per group with a total sample size of 90. An additional 10 participants will be recruited to compensate for possible attrition rate.

Data analysis will be performed using SPSS Version 28.0.0.0. Normality distribution will be assessed for each dependent variable. Two-way ANOVA with one repeated measure (two groups - intervention and control, by two time points - before and after listening to audio file) or the Friedman test will be conducted for each outcome measure, according to the assumptions they meet. The independent variable involves the participant either listening to Chinese instrumental music with Binaural Beats (Theta progressing to Delta Binaural Beats) or Chinese instrumental music without Binaural Beats. The dependent variables are anxiety, mood, stress and pain levels. Post-hoc analyses will then be conducted if significant results are found based on sample characteristics.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
24/07/2023
Date of last participant enrolment
Anticipated
29/02/2024
Actual
4/09/2023
Date of last data collection
Anticipated
31/03/2024
Actual
4/09/2023
Sample size
Target
100
Accrual to date
Final
58
Recruitment outside Australia
Country [1] 25621 0
Singapore
State/province [1] 25621 0
Singapore

Funding & Sponsors
Funding source category [1] 314202 0
University
Name [1] 314202 0
Singapore Institute of Technology
Country [1] 314202 0
Singapore
Primary sponsor type
Individual
Name
Peter Tay Kay Chai
Address
Singapore Institute of Technology @ Dover. 10 Dover Dr, Singapore 138683
Country
Singapore
Secondary sponsor category [1] 316121 0
None
Name [1] 316121 0
Address [1] 316121 0
Country [1] 316121 0
Other collaborator category [1] 282728 0
Individual
Name [1] 282728 0
Agnes Ng Yee Fan
Address [1] 282728 0
Singapore Institute of Technology @ Dover. 10 Dover Dr, Singapore 138683.
Country [1] 282728 0
Singapore
Other collaborator category [2] 282729 0
Individual
Name [2] 282729 0
Alyssa Tay
Address [2] 282729 0
Singapore Institute of Technology @ Dover. 10 Dover Dr, Singapore 138683.
Country [2] 282729 0
Singapore
Other collaborator category [3] 282730 0
Individual
Name [3] 282730 0
Yap Bin Xue
Address [3] 282730 0
Singapore Institute of Technology @ Dover. 10 Dover Dr, Singapore 138683.
Country [3] 282730 0
Singapore
Other collaborator category [4] 282731 0
Individual
Name [4] 282731 0
Lim Wen Hui
Address [4] 282731 0
Singapore Institute of Technology @ Dover. 10 Dover Dr, Singapore 138683.
Country [4] 282731 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313328 0
Singapore Institute of Technology - Institutional Review Board
Ethics committee address [1] 313328 0
Ethics committee country [1] 313328 0
Singapore
Date submitted for ethics approval [1] 313328 0
03/02/2023
Approval date [1] 313328 0
09/06/2023
Ethics approval number [1] 313328 0
RECAS-0003

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

Contacts
Principal investigator
Name 127750 0
Dr Peter Tay Kay Chai
Address 127750 0
Singapore Institute of Technology @ Dover. 10 Dover Dr, Singapore 138683.
Country 127750 0
Singapore
Phone 127750 0
+65 6592 1461
Fax 127750 0
Email 127750 0
[email protected]
Contact person for public queries
Name 127751 0
Peter Tay Kay Chai
Address 127751 0
Singapore Institute of Technology @ Dover. 10 Dover Dr, Singapore 138683.
Country 127751 0
Singapore
Phone 127751 0
+65 6592 1461
Fax 127751 0
Email 127751 0
[email protected]
Contact person for scientific queries
Name 127752 0
Peter Tay Kay Chai
Address 127752 0
Singapore Institute of Technology @ Dover. 10 Dover Dr, Singapore 138683.
Country 127752 0
Singapore
Phone 127752 0
+65 6592 1461
Fax 127752 0
Email 127752 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The information will not be made publicly available as stated in the Participant Consent Form.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19591Ethical approval    386173-(Uploaded-02-07-2023-16-44-33)-Study-related document.pdf
19592Informed consent form    386173-(Uploaded-02-07-2023-16-44-42)-Study-related document.pdf



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.