UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052563 |
|---|---|
| Receipt number | R000059973 |
| Scientific Title | Examination of the effects of essential oil-flavored drinks on stress relief and work efficiency improvement |
| Date of disclosure of the study information | 2023/10/20 |
| Last modified on | 2025/04/22 16:25:44 |
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Basic information
Public title
Stress relaxation test of beverages flavored with essential oils
Acronym
Essential oil-flavored drink test
Scientific Title
Examination of the effects of essential oil-flavored drinks on stress relief and work efficiency improvement
Scientific Title:Acronym
Essential oil-flavored drink test
Region
| Japan |
Condition
Condition
Relief of mental stress in healthy people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the psychological and physical stress-reducing effects and work efficiency improvement effects of consuming a beverage scented with essential oils are equivalent to those of using a diffuser to provide scent stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate variability during a 10-minute calculation task performed while drinking an essential oil-flavored beverage and up to 60 minutes after completing the task
Key secondary outcomes
Mood profiles before and after a 10-minute calculation task performed after drinking an essential oil flavored beverage
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
6
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Intervention 1: Beverage intake, lavender oil
Interventions/Control_2
Intervention 2: Beverage intake, bergamot oil
Interventions/Control_3
Intervention 3: Diffuser inhalation, lavender oil
Interventions/Control_4
Intervention 4: Diffuser inhalation, bergamot oil
Interventions/Control_5
Control 1: Beverage intake, no odor
Interventions/Control_6
Control 2: Diffuser inhalation, odorless
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Having vision and hearing that do not interfere with daily life
Key exclusion criteria
Receiving treatment for mental stress
Having Daily medication
Allergic to bergamot and lavender essential oils
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Shimoda |
Organization
Tokyo University of Agriculture and Technology
Division name
Institute of agriculture
Zip code
1838509
Address
Saiwai-cho 3-5-8, Fuchu, Tokyo
TEL
042-367-5642
shimoda@cc.tuat.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Shimoda |
Organization
Tokyo University of Agriculture and Technology
Division name
Institute of Agriculture
Zip code
1838509
Address
Saiwai-cho 3-5-8, Fuchu, Tokyo
TEL
042-367-5642
Homepage URL
shimoda@cc.tuat.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture and Technology
Institute
Department
Personal name
Funding Source
Organization
Tokyo University of Agriculture and Technology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo University of Agriculture and Technology
Address
Harumi-cho 3-8-1, Fuchu, Tokyo
Tel
042-367-5638
kenrinri@m2.tuat.ac.jp
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
| 2023 | Year | 10 | Month | 20 | 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
| 2023 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059973
