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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019763
Receipt No. R000022784
Scientific Title Psycho-physiological effects of inhalation of essential oils
Date of disclosure of the study information 2015/11/12
Last modified on 2015/12/02

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Basic information
Public title Psycho-physiological effects of inhalation of essential oils
Acronym Psycho-physiological effects of essential oils
Scientific Title Psycho-physiological effects of inhalation of essential oils
Scientific Title:Acronym Psycho-physiological effects of essential oils
Region
Japan

Condition
Condition Psychological stress of healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Healthy adults to examine the changes and psycho-physiological effects of stress reaction in the before and after inhaling the smell of various essential oils.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1.Salivary cortisol
2.Psychological evaluation

Change levels before and after intervention
Comparison of aroma conditions and control conditions

3.Heart rate variability (measurement of the autonomic nervous system)

Change levels on intervention
Comparison of aroma conditions and control conditions
Key secondary outcomes Inhalation of 15 minutes of essential oil steam

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom Other
Interventions/Control_1 1)aroma 15min
2)washout 20min
3)no treatment 15min
Interventions/Control_2 1)no treatment 15min
2)washout 20min
3)aroma 15min
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
25 years-old >
Gender Female
Key inclusion criteria 1) healthy women of age is less than 25 years of age or 20 years of age
2) those who understood the meaning of this test before the start of the test, signed the consent form
Key exclusion criteria The subject of the following conditions
1) pregnancy, breastfeeding
2) chronic disease, acute disease
3) an abrupt change of living environment
4) acute disease, malignant tumor
5) allergies, respiratory diseases
6) of the skin abnormalities
7) Human investigator is judged unsuitable
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eri Watanabe
Organization Kyoto Prefectural Univ. Med.
Division name Dep. Immunology
Zip code
Address Kajii-cyo 465, Kamikyo, Kyoto 602-8566, Japan
TEL 075-251-5329
Email e-w@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eri Watanabe
Organization Kyoto Prefectural Univ. Med.
Division name Dep. Immunology
Zip code
Address Kajii-cyo 465, Kamikyo, Kyoto 602-8566, Japan
TEL 075-251-5329
Homepage URL https://kpu.bvits.com/rinri/Apply/project.aspx?PROJECT_ID=383
Email e-w@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural Univ. Med.
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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 YES
Study ID_1 RBMR-C-338
Org. issuing International ID_1 IRB
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 12 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
2007 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 12 Day
Last modified on
2015 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022784

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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