UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033499
Receipt number 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 11:43:03

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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 or person

Institute

Gunma University

Institute

Department

Personal name



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

Value
https://center6.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