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

Email

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


Email

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

Email

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