UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056679 |
|---|---|
| Receipt number | R000064779 |
| Scientific Title | Effects of regular tempo somatic stimulation on autonomic nervous ; randomized controlled trial |
| Date of disclosure of the study information | 2025/01/15 |
| Last modified on | 2025/01/10 12:06:07 |
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Basic information
Public title
Effects of regular tempo somatic stimulation on autonomic nervous function;A randomized controlled trial
Acronym
Effects of regular tempo somatic stimulation on autonomic nervous function
Scientific Title
Effects of regular tempo somatic stimulation on autonomic nervous ; randomized controlled trial
Scientific Title:Acronym
Effects of regular tempo somatic stimulation on autonomic nervous function
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the influence of touch stimulation with a regular tempo on autonomic nervous function using Heart Rate Variability:HRV analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Instantaneous heart rate is calculated from the R-R interval of the recorded ECG. In addition, HRV analysis is performed as an indicator of cardiac autonomic function.
Key secondary outcomes
The Japanese version of the UWIST Mood Checklist JUMACL will be used to assess mood before and after the experiment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Control group : no treatment
Interventions/Control_2
Intervention group 1 :regular tempo contact stimulation group
Interventions/Control_3
Intervention group 2 :irregular tempo contact stimulation group
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy men and women aged 18 to under 30
Key exclusion criteria
(1) Those who are in the hospital or receiving medication due to an underlying disease
(2) Those with circulatory system abnormalities
(3) Those who have poor physical condition due to sleep disorder
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Imai |
Organization
Teikyo Heisei University
Division name
Graduate School of Health Sciences,
Zip code
170-8445
Address
2-51-4 Higashi-Ikebukuro, Toshima-ku,Tokyo
TEL
03-5843-3111
k.imai1@thu.ac.jp
Public contact
Name of contact person
| 1st name | Toshimi |
| Middle name | |
| Last name | Hiroi |
Organization
Teikyo Heisei University
Division name
Graduate School of Health Sciences,
Zip code
170-8445
Address
2-51-4 Higashi-Ikebukuro, Toshima-ku,Tokyo
TEL
03-5843-3111
Homepage URL
hiroi-t@takasaki-u.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
Teikyo Heisei University
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
Human Research Ethics Committee
Address
2-51-4 Higashi-Ikebukuro, Toshima-ku,Tokyo
Tel
03-5843-3111
rec@thu.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 | 01 | Month | 15 | 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
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | 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 | 01 | Month | 10 | Day |
Last modified on
| 2025 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064779
