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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029626
Receipt No. R000033841
Scientific Title Changes in facial muscle and skin temperature by smile as a simulated laugh using pen holding method
Date of disclosure of the study information 2017/10/19
Last modified on 2018/04/20

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Basic information
Public title Changes in facial muscle and skin temperature by smile as a simulated laugh using pen holding method
Acronym Changes in facial muscle and skin temperature by smile as a simulated laugh using pen holding method
Scientific Title Changes in facial muscle and skin temperature by smile as a simulated laugh using pen holding method
Scientific Title:Acronym 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
1st name
Middle name
Last name imaiyuji watanabekishiko
Organization Niigata University Graduate School of Health Sciences
Division name School of Health Sciences
Zip code
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
1st name
Middle name
Last name imai yuji
Organization Niigata University Graduate School of Health Sciences
Division name School of Health Sciences
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 10 Month 05 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000033841

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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