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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034694
Receipt No. R000039328
Official scientific title of the study Psychological / physiological responses by application of aroma
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/30

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Basic information
Official scientific title of the study Psychological / physiological responses by application of aroma
Title of the study (Brief title) 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 Rie Yamashita
Organization Industrial Research Institute of Shizuoka Prefecture
Division name Wood Science and Technology
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 Industrial Research Institute of Shizuoka Prefecture
Organization Industrial Research Institute of Shizuoka Prefecture
Division name Wood Science and Technology
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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 20 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 10 Month 30 Day
Last modified on
2018 Year 10 Month 30 Day


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

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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