UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059594 |
|---|---|
| Receipt number | R000068170 |
| Scientific Title | The Effects of Deep Micro Vibrotactile (DMV) on Stress in Healthy Adults |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/10/30 18:07:49 |
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Basic information
Public title
The Effects of Deep Micro Vibrotactile (DMV) on Stress in Healthy Adults
Acronym
The Effects of Deep Micro Vibrotactile (DMV) on Stress in Healthy Adults
Scientific Title
The Effects of Deep Micro Vibrotactile (DMV) on Stress in Healthy Adults
Scientific Title:Acronym
The Effects of Deep Micro Vibrotactile (DMV) on Stress in Healthy Adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of deep micro vibrotactile (DMV) stimulation on stress in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes resulting from assessment using the Japanese version of POMS2 (TMD, TA, DD, AH, VA, FI, CB, F).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Deep Micro Vibrotactile
Interventions/Control_2
without treatment
Interventions/Control_3
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Individuals aged 18 or older but under 65 at the time of consent acquisition
2.Individuals who are office workers reporting to work daily
3.Individuals with a TMD score of 60 or higher on the POMS2 at day 0
4.Individuals capable of providing written consent of their own free will
Key exclusion criteria
1.Individuals with a history of treatment for malignant tumors, heart failure, or myocardial infarction
2.Individuals with circadian rhythm disorders
3.Individuals with irregular sleep schedules or habits due to night shifts, etc.
4.Individuals absent on weekdays for STEP 1 and STEP 2 on two or more days per week
5.Individuals regularly taking medications that may affect this clinical study, such as antipsychotics or antidepressants
6.Individuals with a history of alcohol or substance abuse
7.Individuals with severe complications
8.Individuals currently participating in another clinical trial, or who have participated in another clinical trial within the past month
9.Other individuals deemed ineligible by the principal investigator or sub-investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | keiji |
| Middle name | |
| Last name | inoue |
Organization
Kochi Medical School Hospital
Division name
Center for Next Generation Medical Research
Zip code
783-8505
Address
kohasu, okou Town, Nankoku City, Kochi Prefecture
TEL
088-880-2719
keiji@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Iijima |
Organization
Kochi Medical School Hospital
Division name
Center for Next Generation Medical Research
Zip code
783-8505
Address
kohasu, okou Town, Nankoku City, Kochi Prefecture
TEL
088-880-2719
Homepage URL
h.iijima@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi Medical School Hospital
Address
kohasu, okou Town, Nankoku City, Kochi Prefecture
Tel
0888-80-2180
rinri21@kochi-u.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
| 2025 | Year | 11 | Month | 10 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068170
