UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056517 |
|---|---|
| Receipt number | R000064585 |
| Scientific Title | Whether listening to music containing the Solfeggio frequency (528Hz) during the execution of simple arithmetic tasks reduces psychological stress. |
| Date of disclosure of the study information | 2024/12/25 |
| Last modified on | 2025/04/30 11:09:31 |
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Basic information
Public title
Whether listening to music containing the Solfeggio frequency (528Hz) during the execution of simple arithmetic tasks reduces psychological stress.
Acronym
Whether listening to music containing the Solfeggio frequency (528Hz) during the execution of simple arithmetic tasks reduces psychological stress.
Scientific Title
Whether listening to music containing the Solfeggio frequency (528Hz) during the execution of simple arithmetic tasks reduces psychological stress.
Scientific Title:Acronym
Whether listening to music containing the Solfeggio frequency (528Hz) during the execution of simple arithmetic tasks reduces psychological stress.
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether listening to Solfeggio music during simple arithmetic tasks can suppress the increase in salivary amylase levels associated with task-induced stress, compared to silent conditions and general music conditions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
salivary amylase levels
Key secondary outcomes
Uchida-Kraepelin Psychodiagnostic Test results
Profile of Mood States 2 (POMS2)
NASA Task Load Index (NASA-TLX)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Engage in simple arithmetic tasks under silent conditions.
Interventions/Control_2
Listen to music containing 528Hz frequency (Solfeggio music) during simple arithmetic tasks.
Interventions/Control_3
Listen to music with a standard scale during simple arithmetic tasks.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 21 | years-old | <= |
Age-upper limit
| 23 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Third and fourth-year students enrolled in the Faculty of Rehabilitation at Hyogo Medical Univerity.
Key exclusion criteria
Individuals with visual impairments that may affect the performance of the Kraepelin test.
Individuals with hearing impairments that may affect how music is perceived.
Individuals with metabolic disorders that may affect salivary secretion (such as thyroid dysfunction, anemia, hypoglycemia, hypoalbuminemia, etc.).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tsunehiro |
| Middle name | |
| Last name | Otsuka |
Organization
Hyogo Medical University
Division name
Faculty of rehabilitation
Zip code
6508530
Address
1-3-6 Minatojima Cyuouku Kobe Hyogo
TEL
0783043185
ts-ootsuka@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Tsunehiro |
| Middle name | |
| Last name | Otsuka |
Organization
Hyogo Medical University
Division name
Faculty of rehabilitation
Zip code
6508530
Address
1-3-6 Minatojima Cyuouku Kobe Hyogo
TEL
0783043185
Homepage URL
ts-ootsuka@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University ethics committee
Address
1-1 Mukogawacyo Nishinomiya Hyogo
Tel
0798456111
chizai@hyo-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
32
Results
No significant differences were found in correct responses or amylase levels across conditions. The Solfeggio music condition showed lower [Friendliness] (POMS2, p = .04), while [Time Pressure] (NASA-TLX) was lower under general music (p = .02) and tended to decrease with Solfeggio music (p = .05). Only in the Solfeggio condition, amylase changes negatively correlated with [Friendliness] (r = -0.50) and [Vigor-Activity] (r = -0.41).
Results date posted
| 2025 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A student enrolled in the 4th grade of the School of Rehabilitation at Hyogo Medical University.
Participant flow
The study was conducted after providing participants with a written explanation of the procedure and obtaining their informed consent. Participants performed a simple arithmetic task (Uchida-Kraepelin test) under three conditions: general music (music based on a standard scale tuned to 440 Hz), Solfeggio music, and silence. Salivary amylase levels were measured before and after each task as a physiological stress indicator. Additionally, subjective stress was assessed using the short form of the POMS2 and the NASA-TLX. Comparisons were made between conditions in terms of salivary amylase levels and subjective ratings.
The Uchida-Kraepelin test was administered for 10 minutes under each condition, with at least one day between sessions to minimize carryover effects. Testing was scheduled at approximately the same time of day for each participant to control for circadian variations. The auditory stimuli consisted of two types of music: an original composition in C major at 120 BPM using a standard scale (general music), and a pitch-adjusted version of the same composition incorporating Solfeggio frequencies including 528 Hz (Solfeggio music). The order of condition exposure was counterbalanced across participants.
Adverse events
None
Outcome measures
Physiological stress evaluation item: Salivary amylase level
Subjective stress evaluation items: POMS2 (short form), NASA-TLX
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 20 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064585
