UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042146 |
|---|---|
| Receipt number | R000048107 |
| Scientific Title | Verification test of physiological index of pleasure by pleasant stimuli of graded intensity. |
| Date of disclosure of the study information | 2020/10/18 |
| Last modified on | 2025/05/16 02:32:02 |
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Basic information
Public title
Verification test of physiological index of pleasure by pleasant stimuli of graded intensity.
Acronym
Verification test of physiological index of pleasure by pleasant stimuli of graded intensity.
Scientific Title
Verification test of physiological index of pleasure by pleasant stimuli of graded intensity.
Scientific Title:Acronym
Verification test of physiological index of pleasure by pleasant stimuli of graded intensity.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether the physiological response intensity for some physiological parameters obtained as physiological index candidates for pleasure corresponds to the emotional intensity by video stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physiological index candidates for pleasure using parameters in blood circulation.
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
Video stimuli to elicit pleasures of 3 grades of strength
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
30
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
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
006-8585
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
30
Results
For the verification, we used video stimuli with intensity levels of 0 to 2 that evoked positive emotions. As the stimulation level increased, the questionnaire scores increased. The blood pressure waveform parameters we found increased significantly as the stimulation level increased. Furthermore, each parameter showed a significant correlation with the questionnaire's positive emotion scores, suggesting that they may be used as positive emotion axis parameters in a physiological emotion model.
Results date posted
| 2025 | Year | 05 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy young adult male
Participant flow
Adverse events
None
Outcome measures
Physiological quantities
Questionnaire
Correlation coefficient
Plan to share IPD
IPD sharing Plan description
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 | 30 | Day |
Date of closure to data entry
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 | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048107
