UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029910 |
|---|---|
| Receipt number | R000034160 |
| Scientific Title | The effect of autonomic nervous activity and office relaxation in the office |
| Date of disclosure of the study information | 2017/11/13 |
| Last modified on | 2017/11/16 23:31:08 |
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Basic information
Public title
The effect of autonomic nervous activity and office relaxation in the office
Acronym
The effect of autonomic nervous activity and office relaxation in the office
Scientific Title
The effect of autonomic nervous activity and office relaxation in the office
Scientific Title:Acronym
The effect of autonomic nervous activity and office relaxation in the office
Region
| Japan |
Condition
Condition
A healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To understand the autonomic nervous activity of workers working in the office and to examine the effect of intervention in office relaxation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Autonomic nervous activity in the office
Key secondary outcomes
Autonomic nerve activity change before and after office relaxation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention period is 30 minutes to 1 hour a month. Measure the autonomic nervous activity in the office using a pulse wave measuring instrument and separate autonomic nervous activity using a pulse wave measuring instrument before and after office relaxation (body care etc.).
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･20<= years-old
･Male and Female
･Working in office
･A person who is provided sufficient explanations about this study and consented to it in writing by his own free will
Key exclusion criteria
･a person who has any diseases
･a person who is probably pregnant or is during pregnancy
･a person who is during the lactation
･an inappropriate person for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tkuji Arai |
Organization
Management of industry, Graduate School of engineering,Osaka University
Division name
engineering
Zip code
Address
2-1 Yamadaoka Suita-city, Osaka
TEL
06-6877-5111
u318525b@ecs.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tkuji Arai |
Organization
Management of industry, Graduate School of engineering,Osaka University
Division name
engineering
Zip code
Address
2-1 Yamadaoka Suita-city, Osaka
TEL
06-6877-5111
Homepage URL
u318525b@ecs.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
VOYAGE CO., LTD.
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
Address
Tel
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
| 2017 | Year | 11 | Month | 13 | 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
| 2017 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 10 | Day |
Last modified on
| 2017 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034160
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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