UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022577 |
|---|---|
| Receipt number | R000026021 |
| Scientific Title | The Effects of Inhalation of Unique Scent to Japan on Stress Relief: An Experimental Study Using Yuzu Essential Oil and Sakura Flower Cell Extract |
| Date of disclosure of the study information | 2016/06/04 |
| Last modified on | 2017/12/03 18:00:25 |
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Basic information
Public title
The Effects of Inhalation of Unique Scent to Japan on Stress Relief: An Experimental Study Using Yuzu Essential Oil and Sakura Flower Cell Extract
Acronym
The Effects of Inhalation of Unique Scent to Japan on Stress Relief: An Experimental Study Using Yuzu Essential Oil and Sakura Flower Cell Extract
Scientific Title
The Effects of Inhalation of Unique Scent to Japan on Stress Relief: An Experimental Study Using Yuzu Essential Oil and Sakura Flower Cell Extract
Scientific Title:Acronym
The Effects of Inhalation of Unique Scent to Japan on Stress Relief: An Experimental Study Using Yuzu Essential Oil and Sakura Flower Cell Extract
Region
| Japan |
Condition
Condition
healthy female adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effects of inhalation of unique scent to Japan yuzu essential oil and sakura flower cell extract on stress relief.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. salivary cortisol
2. biological antioxidant potential test
Key secondary outcomes
1. change of mood pre- and post-intervention on a scale of one to ten
2. correlations between physical and psychological stress
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
inhalation with sakura flower cell extract for 25 minutes
Interventions/Control_2
inhalation with yuzu essential oil for 25 minutes
Interventions/Control_3
inhalation with lavender essential oil for 25 minutes
Interventions/Control_4
inhalation with water (without essential oil or cell extract) for 25 minutes
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1. subjects without taking medicines
2. subjects who are not pregnant
3. subjects who do not have olfactory disorder
4. subjects who do not have dry mouth (xerostomia)
Key exclusion criteria
subjects who cannot meet the above condition
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuko Okubo |
Organization
St. Luke's International University
Division name
Fundamentals of Nursing/ Biobehaviral Nursing/ Neuroscience of Nursing
Zip code
Address
10-1, Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
03-3543-6391
nobu-okubo@slcn.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayaka Suzuki |
Organization
St. Luke's International University, College of Nursing
Division name
Fundamentals of Nursing/ Biobehaviral Nursing
Zip code
Address
10-1, Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan
TEL
03-3543-6391
Homepage URL
ayaka-suzuki@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
SHIODA Life Science Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 04 | 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
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 04 | Day |
Date of closure to data entry
| 2017 | Year | 11 | Month | 17 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 02 | Day |
Last modified on
| 2017 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026021
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
