UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058216 |
|---|---|
| Receipt number | R000066393 |
| Scientific Title | A Randomized Controlled Trial on the Effects of Gradually Slowing Tempo Vibration Stimulation on Acute Stress Recovery in Healthy Males |
| Date of disclosure of the study information | 2025/06/20 |
| Last modified on | 2025/06/18 13:05:03 |
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Basic information
Public title
A Study on the Stress-Relieving Effects of Vibration Stimulation
Acronym
Vibration Stress Study (VSS)
Scientific Title
A Randomized Controlled Trial on the Effects of Gradually Slowing Tempo Vibration Stimulation on Acute Stress Recovery in Healthy Males
Scientific Title:Acronym
Tempo-Reduced Vibration for Stress Recovery Trial (TRVSR)
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 vibration 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 subjective stress indicators (Tense Arousal [TA] and Energetic Arousal [EA] scores) before and after the intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group 1: Variable vibration stimulation
Participants received a 2-minute vibration stimulation while holding a dedicated device. The vibration started at a tempo corresponding to the participant's resting heart rate (e.g., 75 bpm) and gradually slowed down to either half of the initial heart rate or 50 bpm, whichever was higher.
Interventions/Control_2
Group 2: Fixed vibration stimulation
Participants received a 2-minute vibration stimulation while holding the same device. The vibration was delivered at a fixed tempo set to either half of the participant's resting heart rate or 50 bpm, whichever was higher.
Interventions/Control_3
Group 3: Control group (no stimulation)
Participants held the dedicated vibration device for 2 minutes without receiving any vibration. They rested quietly during this period.
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
| 20 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy males aged 20 to 49 years
Provided written informed consent after receiving sufficient explanation
Key exclusion criteria
Individuals with arrhythmia or cardiovascular disease
Individuals taking medication for the above conditions
Individuals weighing less than 30 kg or more than 100 kg
Individuals using a cardiac pacemaker
Individuals deemed unsuitable for participation in the study by the principal investigator
Target sample size
42
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 | 20 | 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
42
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 | 04 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 08 | 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 | 19 | Day |
Last modified on
| 2025 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066393
