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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022577
Receipt No. R000026021
Scientific Title The Effects of Inhalation of Unique Scent to Japan on Stress Relief: An Experimental Study Using Yuzu Essential Oil and Sakura Flower Cell Extract
Date of disclosure of the study information 2016/06/04
Last modified on 2017/12/03

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Basic information
Public title The Effects of Inhalation of Unique Scent to Japan on Stress Relief: An Experimental Study Using Yuzu Essential Oil and Sakura Flower Cell Extract
Acronym The Effects of Inhalation of Unique Scent to Japan on Stress Relief: An Experimental Study Using Yuzu Essential Oil and Sakura Flower Cell Extract
Scientific Title The Effects of Inhalation of Unique Scent to Japan on Stress Relief: An Experimental Study Using Yuzu Essential Oil and Sakura Flower Cell Extract
Scientific Title:Acronym The Effects of Inhalation of Unique Scent to Japan on Stress Relief: An Experimental Study Using Yuzu Essential Oil and Sakura Flower Cell Extract
Region
Japan

Condition
Condition healthy female adults
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the effects of inhalation of unique scent to Japan yuzu essential oil and sakura flower cell extract on stress relief.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. salivary cortisol
2. biological antioxidant potential test
Key secondary outcomes 1. change of mood pre- and post-intervention on a scale of one to ten
2. correlations between physical and psychological stress

Base
Study type Interventional

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

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 inhalation with sakura flower cell extract for 25 minutes
Interventions/Control_2 inhalation with yuzu essential oil for 25 minutes
Interventions/Control_3 inhalation with lavender essential oil for 25 minutes
Interventions/Control_4 inhalation with water (without essential oil or cell extract) for 25 minutes
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
45 years-old >=
Gender Female
Key inclusion criteria 1. subjects without taking medicines
2. subjects who are not pregnant
3. subjects who do not have olfactory disorder
4. subjects who do not have dry mouth (xerostomia)
Key exclusion criteria subjects who cannot meet the above condition
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuko Okubo
Organization St. Luke's International University
Division name Fundamentals of Nursing/ Biobehaviral Nursing/ Neuroscience of Nursing
Zip code
Address 10-1, Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL 03-3543-6391
Email nobu-okubo@slcn.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayaka Suzuki
Organization St. Luke's International University, College of Nursing
Division name Fundamentals of Nursing/ Biobehaviral Nursing
Zip code
Address 10-1, Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL 03-3543-6391
Homepage URL
Email ayaka-suzuki@slcn.ac.jp

Sponsor
Institute St. Luke's International University
Institute
Department

Funding Source
Organization SHIODA Life Science Inc.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2016 Year 06 Month 04 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
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 04 Day
Last follow-up date
2017 Year 09 Month 04 Day
Date of closure to data entry
2017 Year 11 Month 17 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 06 Month 02 Day
Last modified on
2017 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026021

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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