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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033499
Receipt No. R000038039
Scientific Title Study on the relaxation reaction by the video the flame fluctuates
Date of disclosure of the study information 2018/07/25
Last modified on 2019/07/25

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Basic information
Public title Study on the relaxation reaction by the video the flame fluctuates
Acronym Study on the relaxation reaction by the video the flame fluctuates
Scientific Title Study on the relaxation reaction by the video the flame fluctuates
Scientific Title:Acronym Study on the relaxation reaction by the video the flame fluctuates
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate relaxation reaction by watching video of flame
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Profile of Mood States
Relax degree
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 See the image of fire
Interventions/Control_2 See the image of color
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
28 years-old >=
Gender Male and Female
Key inclusion criteria Students from 18 to 28 years old without visual abnormalities such as color vision disorder and healthy with both mind and body
Key exclusion criteria 1)Those who have experienced past images and actual discomfort in the flame environment
2)Female and those with menstruation
3)If you are not feeling well on the day
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Natsyko Yanagi
Organization Gunma University
Division name Graduate School of Health Sciences
Zip code
Address 3-39-22 Showa-machi,Maebashi,Gunma
TEL 0272207111
Email natsuy@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sayaka Sasaki
Organization Gunma University
Division name School of Health Sciences
Zip code
Address 3-39-22 Showa-machi,Maebashi,Gunma
TEL 0272207111
Homepage URL
Email m15202031@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Gunma University
Organization
Division
Category of Funding Organization Other
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
2018 Year 07 Month 25 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 50
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
2018 Year 07 Month 25 Day
Date of IRB
2018 Year 08 Month 07 Day
Anticipated trial start date
2018 Year 07 Month 25 Day
Last follow-up date
2018 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 24 Day
Last modified on
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038039

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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