UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in facial muscle and skin temperature by smile as a simulated laugh using pen holding method
Title of the study (Brief title)	Changes in facial muscle and skin temperature by smile as a simulated laugh using pen holding method
Region	Japan

Condition
Condition	none
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Measure and analyze changes in movement of facial muscles and change in skin temperature by smile as a simulated laugh using the pen holding method, and examine the relationship with pleasant feelings.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Repetition of the pen holding method increases the contraction of the orbicularis muscle and the large zygomatic muscle, contracting the eye ring muscles and decreasing the skin temperature of the superior orbital artery.
Key secondary outcomes	Repetition of the pen holding method increases pleasant feelings.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	In the pen holding method, it repeats four times to hold disposable chopsticks for 15 seconds. I will take a 30-second break between each implementation.
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	22 years-old >=
Gender	Male and Female
Key inclusion criteria	A healthy adult
Key exclusion criteria	none
Target sample size	20

Research contact person
Name of lead principal investigator	imaiyuji watanabekishiko
Organization	Niigata University Graduate School of Health Sciences
Division name	School of Health Sciences
Address	Niigata-ken Niigata-shi Chuo-ku Asahidomachi 2-746
TEL	025-227-0967
Email	b15n003c@mail.cc.niigata-u.ac.jp

Public contact
Name of contact person	imai yuji
Organization	Niigata University Graduate School of Health Sciences
Division name	School of Health Sciences
Address	Niigata-ken Niigata-shi Chuo-ku Asahidomachi 2-746
TEL	025-227-0967
Homepage URL
Email	b15n003c@mail.cc.niigata-u.ac.jp

Sponsor
Institute	Niigata University
Institute
Department

Funding Source
Organization	Niigata University
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 10 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 05 Day
Anticipated trial start date	2017 Year 10 Month 19 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 04 Month 20 Day
Date trial data considered complete
Date analysis concluded	2018 Year 01 Month 25 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 19 Day
Last modified on	2018 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033841