UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026473 |
|---|---|
| Receipt number | R000028380 |
| Scientific Title | The effect of environmental temperature on social recognition and social decision making |
| Date of disclosure of the study information | 2017/03/20 |
| Last modified on | 2019/03/29 17:08:20 |
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Basic information
Public title
The effect of environmental temperature on social recognition and social decision making
Acronym
The effect of environmental temperature on social recognition and social decision making
Scientific Title
The effect of environmental temperature on social recognition and social decision making
Scientific Title:Acronym
The effect of environmental temperature on social recognition and social decision making
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the effect of environmental temperature on social recognition and social decision making.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recognition performance on memory for unfamiliar faces
Key secondary outcomes
1.Judgement bias on ambiguous facial expression
2.Reaction time on implicit association test of temperature and facial expression
3.Correct response and increment of correct response in manipulation phase from baseline phase in social facilitation task
4.Reaction time and ratio of utilitarian judgement in moral dilemma task
5.Demographic variables: sex, age and psychological traits (individual difference of face recognition performance, social anxiety, empathy, relational mobility)
6.Physiological index: skin temperature, salivary amylase concentration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
High temperature group
Interventions/Control_2
Low temperature group
Interventions/Control_3
Medium temperature group (control)
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Japanese undergraduates and graduate students that can take a day trip to the implementation site of the experiment.
2. Person who have normal vision or corrected normal vision.
3. Person who can well-understand Japanese language.
Key exclusion criteria
Not applicable
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | F |
| Last name | Nakashima |
Organization
Hiroshima Shudo University
Division name
The Faculty of Health Sciences
Zip code
731-3195
Address
1-1-1, Ozuka-higashi, Asaminami-ku, Hiroshima
TEL
082-830-1199
snakashi@shudo-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Nakashima |
Organization
Hiroshima Shudo University
Division name
The Faculty of Health Sciences
Zip code
731-3195
Address
1-1-1, Ozuka-higashi, Asaminami-ku, Hiroshima
TEL
082-830-1199
Homepage URL
snakashi@shudo-u.ac.jp
Sponsor or person
Institute
Hiroshima Shudo University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Senshu University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima shudo University
Address
1-1-1, Ozuka-higashi, Asaminami-ku, Hiroshima
Tel
082-830-1114
r_support@js.shudo-u.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
広島修道大学健康科学部（広島県）、専修大学人間科学部（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 20 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2018 | 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 | 09 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028380
| 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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| Registered date | File name |
