UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of counseling intervention on the stress-reducing effect of bergamot oil and on the concentration-improving effect of rosemary oil in aromatherapy
Title of the study (Brief title)	Influence of counseling intervention in aromatherapy
Region	Japan

Condition
Condition	healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to examine the effectiveness of counseling as a means of improving the stress-reducing efficacy of bergamot oil and the concentration-improving effect of rosemary oil
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	on the stress-reducing effect of bergamot oil and on the concentration-improving effect of rosemary oil in aromatherapy as subjective indicator
Key secondary outcomes	on the change of blood flow in the inferior frontal cortex with near-infrared spectroscopy (NIRS)-evaluated and amylase concentration in saliva as objective indicators.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	bergamota oil
Interventions/Control_2	rosemary oil
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	25 years-old >
Gender	Female
Key inclusion criteria	Female
Key exclusion criteria	Participants who disliked the smell of either of the aromas oils were excluded
Target sample size	23

Research contact person
Name of lead principal investigator	emi nakashima
Organization	Faculty of Pharmacy, Keio University
Division name	Division of PHarmaceutics
Address	1-5-30,Shibakoen, Minato-ku, Tokyo
TEL	03-5400-2660
Email	isawa-mn@pha.keio.ac.jp

Public contact
Name of contact person	Minae Isawa
Organization	Faculty of Pharmacy, Keio University
Division name	Division of PHarmaceutics
Address	1-5-30,Shibakoen, Minato-ku, Tokyo
TEL	03-5400-2660
Homepage URL
Email	isawa-mn@pha.keio.ac.jp

Sponsor
Institute	Faculty of Pharmacy, Keio University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Faculty of Pharmacy, Keio University
Organization
Division
Category of Funding Organization	Other
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	慶應義塾大学薬学部

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 02 Day
Anticipated trial start date	2014 Year 12 Month 02 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2015 Year 08 Month 20 Day
Date trial data considered complete	2015 Year 08 Month 31 Day
Date analysis concluded	2015 Year 09 Month 30 Day

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

Management information
Registered date	2016 Year 05 Month 09 Day
Last modified on	2016 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025636