UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040850 |
|---|---|
| Receipt number | R000046643 |
| Scientific Title | Evaluation study of active-rest effect by fragrance for pro e-sports player. |
| Date of disclosure of the study information | 2020/06/22 |
| Last modified on | 2020/06/22 13:29:33 |
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Basic information
Public title
Evaluation study of active-rest effect by fragrance for pro e-sports player.
Acronym
Evaluation study of active-rest effect by fragrance for pro e-sports player.
Scientific Title
Evaluation study of active-rest effect by fragrance for pro e-sports player.
Scientific Title:Acronym
Evaluation study of active-rest effect by fragrance for pro e-sports player.
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the influence to concentration, relaxation and the quality of sleep when the pro game players smell fragrance during their play.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart beat
Body temperature
Body motion
Acceleration
Subjective evaluation
*Questionnaire about sleep and condition
*Questionnaire about mood before the play
*Questionnaire about performance of the play
*Questionnaire about mood after the play
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Play game for 3 hrs a day with green fragrance for 7 days. Wear heart rate monitor for 24 hrs.
Interventions/Control_2
Play game for 3 hrs a day without any fragrance for 7 days. Wear heart rate monitor for 24 hrs.
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Professional player of TEKKEN 7.
2)Who shows understanding of this study procedures and agreement with participating the study by written informed consent prior to the study.
3)Who can fill in the questionnaires.
4)Healthy individuals
Key exclusion criteria
1)Who has/may have allergy.
2)Who are pregnant or are lactating.
3)Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | AKARI |
| Middle name | |
| Last name | HOSHI |
Organization
ROHTO Pharmaceutical Co., Ltd.
Division name
Business Strategy Office
Zip code
1050014
Address
ROHTO Tokyo Bldg F5. 1-7-5, Shiba, Minato-ku, Tokyo
TEL
080-9931-8609
hoshi@rohto.co.jp
Public contact
Name of contact person
| 1st name | AMI |
| Middle name | |
| Last name | MIURA |
Organization
KANSEI Projects Committee
Division name
Project Coordinator
Zip code
1540011
Address
#6 THE FORUM setagaya 5-15-15 Kamiuma Setagaya, Tokyo
TEL
080-5693-4413
Homepage URL
miura@kanseiproject.com
Sponsor or person
Institute
ROHTO Pharmaceutical Co., Ltd.
Business Strategy Office
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical Co., Ltd.
Business Strategy Office
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Review Committee
Address
1-8-1 Tatsumi nishi Ikuno Osaka, Osaka
Tel
0774-71-8820
takeuchiy@rohto.co.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 22 | 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
2
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 22 | Day |
Last modified on
| 2020 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046643
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
