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Trial registered on ANZCTR


Registration number
ACTRN12624000430538p
Ethics application status
Submitted, not yet approved
Date submitted
8/12/2023
Date registered
9/04/2024
Date last updated
9/04/2024
Date data sharing statement initially provided
9/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of listening to Monaural Beats (at 40Hz) with TENG instrumental music on symptoms of grief in adults
Scientific title
Effects of listening to Monaural Beats (at 40Hz) with TENG instrumental music on affective and cognitive adjustment of grief as compared to listening to TENG instrumental music without Monaural Beats in adults
Secondary ID [1] 311147 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Affective and Cognitive symptoms relating to grief 332313 0
Condition category
Condition code
Mental Health 329021 329021 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Materials used:
-Auditory stimulation with a 40 Hz Monaural Beats (MB) overlaid with TENG instrumental music

Procedures:
-The participants will be randomly assigned to either the MB stimulation group or the control group and will be blinded to the content of the soundtrack and the true nature of the study. All participants will undergo a grief-induction procedure (Lee, Roberts, & Gibbons, 2013). The participants are requested to provide details about their latest experience of loss in one to two paragraphs. This includes information about their connection with the deceased person, the amount of time that had passed since the individual's passing, their emotional proximity to the person, and the circumstances of the person's demise. Additionally, participants are encouraged to share insights about the personality traits of the departed individual, their most cherished memory involving that person, and the emotions they have been experiencing following the loss. After writing their loss experience, the participants will receive the designated auditory stimulus for twenty minutes once in a single session. Outcome measures will be conducted to measure changes in affective and cognitive indicators of grief. Participants' feedback and experiences during the intervention will also be collected through open-ended questions after the intervention. In all, each session will last approximately 1.5 hours.

Who will deliver?
-4 students from Singapore Institute of Technology (SIT) (Year 3, Occupational Therapy)

Mode of delivery:
-Face to face, one-on-one

Number of times/duration/intensity intervention is delivered:
-Once, 20minutes

Location:
-One of the classroom in SIT Dover campus

Characteristics of intervention:
-Generalized (all individuals in the same group will receive the same intervention)
-No need to assess for adherence
Intervention code [1] 327590 0
Treatment: Other
Comparator / control treatment
The control group will receive a placebo auditory stimulus consisting of only the TENG instrumental music.
Control group
Placebo

Outcomes
Primary outcome [1] 336823 0
Affect
Timepoint [1] 336823 0
Pre-intervention and immediately post-intervention
Primary outcome [2] 336824 0
Anxiety
Timepoint [2] 336824 0
Pre-intervention and immediately post-intervention
Primary outcome [3] 336826 0
Verbal free recall
Timepoint [3] 336826 0
Immediately post-intervention
Secondary outcome [1] 429753 0
Cognitive processing of emotional stimuli
Timepoint [1] 429753 0
Immediately post-intervention
Secondary outcome [2] 429754 0
Emotion processing
Timepoint [2] 429754 0
Immediately post-intervention
Secondary outcome [3] 429755 0
Grief
Timepoint [3] 429755 0
Immediately post-intervention
Secondary outcome [4] 432340 0
False recall
Timepoint [4] 432340 0
Immediately post-intervention

Eligibility
Key inclusion criteria
Adults aged 18 to 59 years old
Minimum age
18 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any self-reported hearing problems and other conditions that affect hearing and cognition.
2. Self-reported diagnosed mental disorders and personality disorders.

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)
Concealed
-The participants will be randomly assigned to either the MB stimulation group or the control group and will be blinded to the content of the soundtrack and the true nature of the study.
-Two audio tracks with and without MB, both with TENG music using instruments including erhu, cello, Dizi, keyboard, and guitar, will be produced by the TENG Company Ltd. A consistent 40 Hz MB will be applied throughout the 20-min soundtrack. The soundtracks will be labelled by the TENG Company as “A” and “B” and researchers will not know the contents until the end of the data collection phase to ensure double blinding. The participants will listen to these soundtracks through two speakers provided by the TENG Company.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Number of participants determined using G* Power Analysis (effect size assumed to be of medium, 0.05).

The data will be analysed using analysis of t-tests and ANCOVA, to compare the outcomes between the MB stimulation group and the control group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/04/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 26025 0
Singapore
State/province [1] 26025 0

Funding & Sponsors
Funding source category [1] 315402 0
Commercial sector/Industry
Name [1] 315402 0
The TENG Company
Country [1] 315402 0
Singapore
Primary sponsor type
University
Name
Singapore Institute of Technology
Address
10 Dover Drive Singapore 138683
Country
Singapore
Secondary sponsor category [1] 317464 0
Commercial sector/Industry
Name [1] 317464 0
The TENG Company
Address [1] 317464 0
1 Straits Blvd, #11-03E Singapore Chinese Cultural Centre, Singapore 018906
Country [1] 317464 0
Singapore

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314319 0
Singapore Institute of Technology Institutional Review Board
Ethics committee address [1] 314319 0
Ethics committee country [1] 314319 0
Singapore
Date submitted for ethics approval [1] 314319 0
08/03/2024
Approval date [1] 314319 0
Ethics approval number [1] 314319 0

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

Contacts
Principal investigator
Name 131170 0
A/Prof Peter Kay Chai Tay
Address 131170 0
10 Dover Drive Singapore 138683 (Singapore Institute of Technology)
Country 131170 0
Singapore
Phone 131170 0
+65 6592 1461
Fax 131170 0
Email 131170 0
peter.tay@singaporetech.edu.sg
Contact person for public queries
Name 131171 0
Peter Kay Chai Tay
Address 131171 0
10 Dover Drive Singapore 138683 (Singapore Institute of Technology)
Country 131171 0
Singapore
Phone 131171 0
+65 6592 1461
Fax 131171 0
Email 131171 0
peter.tay@singaporetech.edu.sg
Contact person for scientific queries
Name 131172 0
Peter Kay Chai Tay
Address 131172 0
10 Dover Drive Singapore 138683 (Singapore Institute of Technology)
Country 131172 0
Singapore
Phone 131172 0
+65 6592 1461
Fax 131172 0
Email 131172 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
To ensure confidentiality in participant’s personal information.


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.