UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022249 |
|---|---|
| Receipt number | R000025636 |
| Scientific Title | Influence of counseling intervention on the stress-reducing effect of bergamot oil and on the concentration-improving effect of rosemary oil in aromatherapy |
| Date of disclosure of the study information | 2016/06/30 |
| Last modified on | 2016/05/09 16:27:26 |
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Basic information
Public title
Influence of counseling intervention on the stress-reducing effect of bergamot oil and on the concentration-improving effect of rosemary oil in aromatherapy
Acronym
Influence of counseling intervention in aromatherapy
Scientific Title
Influence of counseling intervention on the stress-reducing effect of bergamot oil and on the concentration-improving effect of rosemary oil in aromatherapy
Scientific Title:Acronym
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.
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
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
| 1st name | |
| Middle name | |
| Last name | emi nakashima |
Organization
Faculty of Pharmacy, Keio University
Division name
Division of PHarmaceutics
Zip code
Address
1-5-30,Shibakoen, Minato-ku, Tokyo
TEL
03-5400-2660
isawa-mn@pha.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minae Isawa |
Organization
Faculty of Pharmacy, Keio University
Division name
Division of PHarmaceutics
Zip code
Address
1-5-30,Shibakoen, Minato-ku, Tokyo
TEL
03-5400-2660
Homepage URL
isawa-mn@pha.keio.ac.jp
Sponsor or person
Institute
Faculty of Pharmacy, Keio University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2014 | Year | 12 | Month | 02 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025636
