UMIN-CTR Clinical Trial

Basic information
Public title	Psychological / physiological responses by application of aroma
Acronym	Psychological / physiological responses by application of aroma
Scientific Title	Psychological / physiological responses by application of aroma
Scientific Title:Acronym	Psychological / physiological responses by application of aroma
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of aroma on psychological / physiological response.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in salivary cortisol concentration as a stress indicator when smelling citrus scent or odorless air for 15 minutes in a stress-loaded state by a stroop test.
Key secondary outcomes	Changes in psychological state, cerebral blood flow (forehead), fluctuation distribution of finger tip pulse waves, and fingertip blood flow when sniffing citrus scent or odorless air for 15 minutes in a stress-loaded state by the stroop test.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	The test is conducted twice per person, divided into two days. In one test, perform the following tests I to III at regular intervals. I In a rest state, sniff the citrus scent for 5 minutes. II In the stress load condition by the stroop test, sniff the citrus fragrance for 15 minutes. III In the stress-loaded state by the stroop test, sniff the odorless air for 15 minutes.
Interventions/Control_2	The test is conducted twice per person, divided into two days. In one test, perform the following tests I to III at regular intervals. I In a rest state, sniff the citrus scent for 5 minutes. II In the stress load condition by the stroop test, sniff the odorless air for 15 minutes. III In the stress-loaded state by the stroop test, sniff the citrus fragrance for 15 minutes.
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	30 years-old <=
Age-upper limit	59 years-old >=
Gender	Female
Key inclusion criteria	(1)Japanese (2)Female (3)Age:30-59, Healthy person (At obtaining informed consent) (4)Persons giving written informed consent
Key exclusion criteria	(1) Subjects who are sensitive to scent and may cause indefinite complaints or asthma. (3) Subjects who have diseases related to blood circulation disorder. (6) Subjects who have skin symptoms around the site of observation that affect the evaluation. For example, scratches, pimples, etc. (7) Subjects who currently go to dermatology office. (8) Subjects who are pregnant, may be pregnant in near future, or are breast-feeding. (9) Subjects who participate in other clinical studies.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Rie Middle name Last name Yamashita
Organization	Industrial Research Institute of Shizuoka Prefecture
Division name	Food Science and Technology
Zip code	421-1298
Address	2078 Makigaya, Aoi-ku, Shizuoka-city, Shizuoka, 421-1298, Japan
TEL	+81-54-278-3024
Email	rie1_yamashita@pref.shizuoka.lg.jp

Public contact
Name of contact person	1st name Rie Middle name Last name Yamashita
Organization	Industrial Research Institute of Shizuoka Prefecture
Division name	Food Science and Technology
Zip code	421-1298
Address	2078 Makigaya, Aoi-ku, Shizuoka-city, Shizuoka, 421-1298, Japan
TEL	+81-54-278-3024
Homepage URL
Email	rie1_yamashita@pref.shizuoka.lg.jp

Sponsor
Institute	Industrial Research Institute of Shizuoka Prefecture
Institute
Department

Funding Source
Organization	Shizuoka prefecture
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Review Board of Industrial Research Institute of Shizuoka Prefecture
Address	2078 Makigaya, Aoi-ku, Shizuoka-city, Shizuoka, 421-1298, Japan
Tel	+81542783028
Email	sk-kikaku@pref.shizuoka.lg.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	静岡県工業技術研究所 Industrial Research Institute of Shizuoka Prefecture

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 01 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	2018 Year 10 Month 20 Day
Date of IRB	2018 Year 10 Month 20 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2019 Year 03 Month 29 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 10 Month 30 Day
Last modified on	2021 Year 11 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039328