UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Effects of Inhalation of Unique Scent to Japan on Stress Relief: An Experimental Study Using Yuzu Essential Oil and Sakura Flower Cell Extract
Title of the study (Brief 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
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	Nobuko Okubo
Organization	St. Luke's International University
Division name	Fundamentals of Nursing/ Biobehaviral Nursing/ Neuroscience of Nursing
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	Ayaka Suzuki
Organization	St. Luke's International University, College of Nursing
Division name	Fundamentals of Nursing/ Biobehaviral Nursing
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000026021