Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001196730
Ethics application status
Approved
Date submitted
29/07/2022
Date registered
7/09/2022
Date last updated
7/09/2022
Date data sharing statement initially provided
7/09/2022
Date results information initially provided
7/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Binaural Beats in Music from The TENG Ensemble on Stress in Singapore University Students: A Randomized Controlled Trial
Scientific title
Effectiveness of Binaural Beats in Music from The TENG Ensemble on Stress in Singapore University Students: A Randomized Controlled Trial
Secondary ID [1] 307682 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 327430 0
Stress 327496 0
Condition category
Condition code
Mental Health 324356 324356 0 0
Other mental health disorders
Mental Health 324554 324554 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This was a randomised controlled trial to examine the effectiveness of a sound therapy call Binaural Beats embedded in instrumental music towards relieving stress among university students. University students participated in the single-session study and were randomized to listen to instrumental music with binaural beats (n=52) and instrumental music without binaural beats (n=52) for thirty minutes while seated comfortably in a quiet room located on the campus. Up to two participants were in the room at any time with safe distancing between them. The soundtracks were delivered over headphones. For the instrumental music with binaural beats group, the music is identical to the soundtrack without the binaural beats. In the music with binaural beats soundtrack, the music flow dynamically from theta to delta brainwaves in 30 minutes with the first 10 minutes occupied by theta wave (8 Hz to 4 Hz) and the remaining in the delta range (4 Hz to 0.5 Hz). Both soundtracks are produced exclusively by The TENG Company Ltd and are currently not available in the public domain. To ensure adherence, the occupational therapy students read the following script to all participants before the listening task “for the next 30 minutes, you will be listening to an audio track through the headphones in front of you. After you put on the headphones, please focus on the track that is playing and avoid all forms of distractions such as using your mobile phone. You may adjust the volume in front of you using the laptop if you find the volume too low or high. Do you have any questions before we begin?”
Intervention code [1] 324159 0
Treatment: Other
Intervention code [2] 324292 0
Behaviour
Comparator / control treatment
The current study included one control condition (1) an audiobook on the history of Chinese instrumental music (n=47). This has been source from public domain (https://www.youtube.com/watch?v=NXEQpv6T84c&list=PLo8_nCspV1QNbS8znFXcpk3Zy9er2aynZ)* and edited to 30-minutes for the current study. The YouTube link has since been deactivated and is no longer available. Reference: Noah Mob (2010). The history of Chinese musical instruments - Part 1.1.
Control group
Active

Outcomes
Primary outcome [1] 332159 0
The State-Trait Anxiety Inventory (STAI Form Y) was used to evaluate participants’ perceived anxiety levels. It is a 40-item self-report measure consisting of 20 items measuring anxiety relating to a situation (STAI-S) and 20 items measuring anxiety associated with personal characteristics (STAI-T). Participants will be required to rate themselves on all items on a 4-point Likert scale. A high score indicates high anxiety level. All participants (N=151) answered the STAI-S questions before and after listening to the soundtracks; all participants (N=151) answered the STAI-T questions before listening to the soundtracks.

Final year occupational therapy students delivered the intervention in seminar rooms within the university campus.
Timepoint [1] 332159 0
The STAI-S was administered at baseline (prior to the 30-minute listening task), and post-intervention (after completion of the 30-minute listening task). The STAI-T was administered at baseline (prior to the 30-minute listening task).
Primary outcome [2] 332160 0
Of the full sample (N=151), the last thirty-two participants underwent physiologic measurement for skin conductance. That is, the final thirty-two participants recruited for the study had their physiologic measures taken. The measurement was obtained using the Shimmer Biosensor attached to the participants' fingers. High number of epochs indicates high arousal.
Timepoint [2] 332160 0
The skin conductance data is collected throughout the 30-minute listening task.
Primary outcome [3] 332380 0
Perceived Stress Scale (PSS) is a 10-item self-report global stress measure, capturing an individual's perception of how uncontrollable, unpredictable, and overloading the stresses in his/her life are in the past month. Participants responded to the items on a 5-point Likert scale. A high total score indicates high chronic stress. All participants (N=151) answered the PSS questions before and after listening to the soundtracks.

Final year occupational therapy students delivered the intervention in seminar rooms within the university campus.

Timepoint [3] 332380 0
The PSS was administered at baseline (prior to the 30-minute listening task), and post-intervention (after completion of the 30-minute listening task).
Secondary outcome [1] 412421 0
Of the full sample (N=151), the last thirty-two participants underwent physiologic measurement for heart rate. That is, the final thirty-two participants recruited for the study had their physiologic measures taken. The measurement was obtained using the Shimmer Biosensor attached to the participants' fingers. High number of epochs indicates high arousal.
Timepoint [1] 412421 0
The heart rate is collected throughout the 30-minute listening task.
Secondary outcome [2] 413249 0
After the listening task, the participants were asked:
Any discomfort experienced during the session? (Yes, No)
If yes, what discomfort did you experience?
Do you listen to Chinese instrumental music? (Purely instrumental with no lyrics)
If not, would you consider listening to Chinese instrumental music after this experience?
If yes, how often do you listen to Chinese instrumental music?
Do you have any music background (i.e. had taken official music lessons for at least one
year)? (Yes, No)
Timepoint [2] 413249 0
All participants were asked this set of questions following the listening task.

Eligibility
Key inclusion criteria
1. University students in Singapore, aged 18 to 35 years old.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Students with a history of epilepsy and profound hearing loss due to the nature of study.
2. Students with cardiovascular disorders and a history of diagnosed mental health conditions as the study’s current focus is on healthy participants.

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)
This is a double-blind randomised controlled trial where researchers received the 3 soundtracks from the soundtrack producers labelled as 'A', 'B' and 'C'. Both researchers and participants do not know which tracks the alphabet labels represent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer.
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
Statistical analysis was performed using SPSS version 28.0. Descriptive statistics were used to summarize participants’ sociodemographic data. Parametric tests were conducted for variables with normal distributions while non-parametric tests were conducted for variables with skewed distributions. One-way analysis of variance (ANOVA) was conducted to determine the significance of changes across the three conditions (i.e., instrumental music with binaural beats, instrumental music only, audio book) for each outcome measure including situational anxiety, affective states, skin conductance and heart rate. Post-hoc analysis, Tukey’s Honest Significant Difference (HSD) test, was conducted to identify the pairs of conditions that are significantly different. In addition, the General Linear Model (GLM) repeated measures were additionally conducted to examine whether there were any interaction effects among the predictor variables including the conditions and covariates outlined above. The level of significance was set at p<0.05 for all analyses and p<.10 were reported as marginal significance.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
24/08/2021
Date of last participant enrolment
Anticipated
Actual
12/11/2021
Date of last data collection
Anticipated
Actual
12/11/2021
Sample size
Target
240
Accrual to date
Final
151
Recruitment outside Australia
Country [1] 24925 0
Singapore
State/province [1] 24925 0

Funding & Sponsors
Funding source category [1] 311951 0
Commercial sector/Industry
Name [1] 311951 0
The TENG Company Ltd
Country [1] 311951 0
Singapore
Primary sponsor type
University
Name
Singapore Institute of Technology
Address
10 Dover Dr, Singapore 138683
Country
Singapore
Secondary sponsor category [1] 313438 0
None
Name [1] 313438 0
Address [1] 313438 0
Country [1] 313438 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311383 0
Singapore Institute of Technology - Institutional Review Board
Ethics committee address [1] 311383 0
10 Dover Dr, Singapore 138683
Ethics committee country [1] 311383 0
Singapore
Date submitted for ethics approval [1] 311383 0
11/03/2021
Approval date [1] 311383 0
26/03/2021
Ethics approval number [1] 311383 0
2021054

Summary
Brief summary
Binaural beats therapy is an emerging form of sound wave therapy with a range of reported psychological benefits. In the current study, musicians from the TENG Company produced a novel audio track by incorporating a dynamic progression of binaural beats from theta to delta waves in instrumental music and the researchers investigated the effect of this music on psychological stress and physiological arousal. We predicted that listening to instrumental music with binaural beats leads to beneficial psychological and physiological changes compared to listening to the same piece of music without binaural beats or an audiobook.

One hundred and fifty-one university students participated in the study and were randomized to listen to instrumental music with binaural beats (n=52), instrumental music without binaural beats (n=52), or audiobook (n=47) for thirty minutes. Of which, thirty-two participants underwent physiologic measurement; they listened to instrumental music with binaural beats (n=10), instrumental music without binaural beats (n=12), or an audiobook (n=10). All participants answered sociodemographic and psychologic questions before and after listening to the soundtracks.
Trial website
Trial related presentations / publications
Public notes
Nil.

Contacts
Principal investigator
Name 120902 0
Dr Peter Tay
Address 120902 0
Peter Tay
Singapore Institute of Technology
10 Dover Dr, Singapore 138683
Country 120902 0
Singapore
Phone 120902 0
+65 65921461
Fax 120902 0
Email 120902 0
Peter.Tay@singaporetech.edu.sg
Contact person for public queries
Name 120903 0
Dr Peter Tay
Address 120903 0
Peter Tay
Singapore Institute of Technology
10 Dover Dr, Singapore 138683
Country 120903 0
Singapore
Phone 120903 0
+65 65921461
Fax 120903 0
Email 120903 0
Peter.Tay@singaporetech.edu.sg
Contact person for scientific queries
Name 120904 0
Dr Peter Tay
Address 120904 0
Peter Tay
Singapore Institute of Technology
10 Dover Dr, Singapore 138683
Country 120904 0
Singapore
Phone 120904 0
+65 65921461
Fax 120904 0
Email 120904 0
Peter.Tay@singaporetech.edu.sg

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Researchers are bounded by the ethical board within the universities and the The Data Protection Act - Personal Data Protection Act Law in Singapore.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16773Informed consent form    384461-(Uploaded-12-08-2022-01-06-13)-Study-related document.docx
16774Ethical approval    384461-(Uploaded-29-07-2022-16-04-52)-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.