UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042144 |
|---|---|
| Receipt number | R000048105 |
| Scientific Title | Study on physiological responses to unpleasant stimuli. |
| Date of disclosure of the study information | 2020/10/18 |
| Last modified on | 2025/05/12 22:20:06 |
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Basic information
Public title
Study on physiological responses to unpleasant stimuli.
Acronym
Study on physiological responses to unpleasant stimuli.
Scientific Title
Study on physiological responses to unpleasant stimuli.
Scientific Title:Acronym
Study on physiological responses to unpleasant stimuli.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate and compare physiological responses to various unpleasant stimuli.
Basic objectives2
Others
Basic objectives -Others
- Relevance between emotions and physiological responses elicited by unpleasant stimuli.
- Relevance between different unpleasant stimulus responses.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of blood circulation and autonomic nervous system.
Key secondary outcomes
questionnaire
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Unpleasant stimuli
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
| 18 | years-old | <= |
Age-upper limit
| 24 | years-old | >= |
Gender
Male
Key inclusion criteria
Young healthy adult male
Key exclusion criteria
- Intake of drugs.
- Sleep deprivation
- physical deconditioning
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Masaji |
| Middle name | |
| Last name | Yamashita |
Organization
Hokkaido University of Science
Division name
Faculty of Health Sciences
Zip code
006-8585
Address
7-15-4-1 Maeda, Teine, Sapporo
TEL
011-688-2230
yamashita@hus.ac.jp
Public contact
Name of contact person
| 1st name | Masaji |
| Middle name | |
| Last name | Yamashita |
Organization
Hokkaido University of Science
Division name
Faculty of Health Sciences
Zip code
8585
Address
7-15-4-1 Maeda, Teine, Sapporo
TEL
011-688-2230
Homepage URL
yamashita@hus.ac.jp
Sponsor or person
Institute
Hokkaido University of Science
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Hokkaido University of Science
Address
7-15-4-1 Maeda, Teine, Sapporo
Tel
011-688-2241
kenkyu@hus.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
北海道科学大学
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
90
Results
We investigated physiological responses common to multiple unpleasant emotions with different arousal levels. Using the blood pressure waveform analysis method we developed, we found that multiple waveform components changed in common only in response to unpleasant stimuli with different arousal levels. The cross-correlation between these parameters and questionnaire scores was significant. In the deep learning analysis of blood pressure waveforms, the identification rate of unpleasant stimuli reached 90%.
Results date posted
| 2025 | Year | 05 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy young male adult
Participant flow
Adverse events
None
Outcome measures
Parameters of blood pressure wave component, physiological parameters, questionnaire scores, cross-correlation rates, identification rates
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
| 2025 | Year | 05 | Month | 15 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 17 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048105
