UMIN-CTR Clinical Trial

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
Last 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
Email	snakashi@shudo-u.ac.jp

Public contact
1st 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
Email	snakashi@shudo-u.ac.jp

Sponsor
Institute	Hiroshima Shudo University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028380