UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026763 |
|---|---|
| Receipt number | R000030727 |
| Scientific Title | Study of stress measurement by driving simulator |
| Date of disclosure of the study information | 2017/03/29 |
| Last modified on | 2022/04/04 13:22:25 |
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Basic information
Public title
Study of stress measurement by driving simulator
Acronym
Study of stress measurement by driving simulator
Scientific Title
Study of stress measurement by driving simulator
Scientific Title:Acronym
Study of stress measurement by driving simulator
Region
| Japan |
Condition
Condition
Stress with operation of the motor vehicle
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this research, by analyzing the cardiovascular response at the time of stress, by applying response measurement of heart rate and pulse wave at the time of audio-visual stimulation by a drive simulator using a head mounted display or a high definition large display, To realize the quantitative evaluation of stress. The ultimate goal is to realize system development to quantify the reaction at the time of driving a car and to prevent traffic accidents.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perform simulated operation with an automobile driving simulator, and perform electrocardiogram, photoelectric pulse wave, blood pressure measurement. Electrocardiogram electrode, photoelectric pulse wave sensor, blood pressure cuff are used to measure change in electrocardiogram, pulse wave, blood pressure.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Use a head mounted display or a large display to watch a movie while driving a car and simulate it with an automobile driving simulator, and perform electrocardiogram, photoelectric pulse wave, blood pressure measurement.
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
Target healthy male and female 20 years of age or older who have a driver's license.
Key exclusion criteria
Motion sickness, people with severe visual sickness are excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Yambe |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer
Zip code
9808575
Address
Seiryo-machi 4-1, Aoba-ku Sendai, 980-8575, JAPAN
TEL
022-717-8517
tomoyuki.yambe.a4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | akihiro |
| Middle name | |
| Last name | yamada |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer
Zip code
9808575
Address
Seiryo-machi 4-1, Aoba-ku Sendai, 980-8575, JAPAN
TEL
022-717-8517
Homepage URL
akihiro.yamada.e1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku 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
Ethics Committee Tohoku University Graduate School of Medicine
Address
seiryo 2-1, Aoba-ku, Sendai, 980-8575, JAPAN
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2017 | Year | 03 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2025 | 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
| 2017 | Year | 03 | Month | 29 | Day |
Last modified on
| 2022 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030727
