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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026763
Receipt No. R000030727
Scientific Title Study of stress measurement by driving simulator
Date of disclosure of the study information 2017/03/29
Last modified on 2019/04/01

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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
Email 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
Email akihiro.yamada.e1@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Email 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
2020 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
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030727

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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