UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058197 |
|---|---|
| Receipt number | R000066418 |
| Scientific Title | A Confirmatory Trial on Acute Stress Recovery Using Combined Vibration and Music Stimulation with Gradually Slowing Tempo |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/06/16 18:15:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study on Stress Reduction Effects of Combined Vibration and Music Stimulation
Acronym
Vibro-Music Stress Study (VMSS-2)
Scientific Title
A Confirmatory Trial on Acute Stress Recovery Using Combined Vibration and Music Stimulation with Gradually Slowing Tempo
Scientific Title:Acronym
Tempo-Synchronized Vibro-Music Stimulation for Stress Recovery (TSVMSSR)
Region
| Japan |
Condition
Condition
None (Healthy participants)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effects of gradually slowing tempo synchronized vibration and music stimulation on acute stress recovery in healthy male participants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in stress indicators (salivary cortisol concentration, VAS, Jikaku-sho Shirabe, and Emotion and Mood Inventory) before and after the intervention under acute stress conditions. Although the study protocol originally specified autonomic nervous system indicators (e.g., HRV) as the primary outcomes, they could not be analyzed due to data quality issues. Therefore, the above indicators were registered and reported as the primary outcomes.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Variable vibration plus music stimulation
Combined vibration and music stimulation synchronized to the participant's heart rate and gradually slowed to 50 bpm, delivered for approximately 4 minutes via headphones and a handheld vibration device.
Interventions/Control_2
Music only
Participants listened to music only for approximately 4 minutes via headphones. Vibration was not delivered, but the vibration device was held.
Interventions/Control_3
Control (no stimulation)
Participants wore headphones and held the vibration device, but received no stimulation for approximately 4 minutes.
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
| 25 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
- Healthy males aged 25 to 49 years
- Provided written informed consent after full explanation
Key exclusion criteria
History of severe physical illness
History of treatments or use of medications that may influence autonomic nervous function
Discomfort during hearing tests or when wearing headphones
Inability to maintain regular daily routines during the study period
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | tomonori |
| Middle name | |
| Last name | motokawa |
Organization
POLA Chemical Industries, Inc.
Division name
Frontier Research Center
Zip code
244-0812
Address
560, kasio-cho, totsuka-ku, yokohama, kanagawa, JAPAN
TEL
045-826-7134
motchy.motchy@mail.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | tomomi |
| Middle name | |
| Last name | kato |
Organization
POLA Chemical Industries, Inc.
Division name
Frontier Research Center
Zip code
244-0812
Address
560, kasio-cho, totsuka-ku, yokohama, kanagawa, JAPAN
TEL
045-826-7134
Homepage URL
k-tomo@pola.co.jp
Sponsor or person
Institute
POLA Chemical Industries, Inc.
Institute
Department
Personal name
Funding Source
Organization
POLA Chemical Industries, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
POLA Chemical Industries, Inc.
Address
560, kasio-cho, totsuka-ku, yokohama, kanagawa, JAPAN
Tel
045-826-7134
y-miyasaka@pola.co.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
| 2025 | Year | 06 | Month | 30 | 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
36
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066418
