UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054928 |
|---|---|
| Receipt number | R000062747 |
| Scientific Title | Verification of the Anxiety-Reducing Effect of Bergamot Essential Oil on Aromastone before Exams: A Parallel Group Comparative Study |
| Date of disclosure of the study information | 2024/07/10 |
| Last modified on | 2024/07/25 22:03:15 |
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Basic information
Public title
Verification of the Anxiety-Reducing Effect of Bergamot Essential Oil on Aromastone before Exams: A Parallel Group Comparative Study
Acronym
Verification of the Anxiety-Reducing Effect of Bergamot Essential Oil on Aromastone before Exams: A Parallel Group Comparative Study
Scientific Title
Verification of the Anxiety-Reducing Effect of Bergamot Essential Oil on Aromastone before Exams: A Parallel Group Comparative Study
Scientific Title:Acronym
Verification of the Anxiety-Reducing Effect of Bergamot Essential Oil on Aromastone before Exams: A Parallel Group Comparative Study
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the anxiety-reducing effect before exams through the use of an aromastone with bergamot essential oil.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Evaluate the anxiety-reducing effect of the scent of bergamot essential oil based on the changes from baseline in SAI before and after the intervention.
Key secondary outcomes
Evaluate the relaxation effect of the scent of bergamot essential oil based on the changes in S-MARE before and after the intervention.
Evaluate the depression, anxiety, and stress reduction effects of the scent of bergamot essential oil based on the changes in DASS-21 before and after the intervention.
Evaluate the improvement effect on subjective well-being of the scent of bergamot essential oil based on the changes in SHS before and after the intervention.
Evaluate the effects on concentration, learning motivation, and fatigue improvement of the scent of bergamot essential oil based on the changes in NRS before and after the intervention.
Evaluate the improvement effect on sleepiness of the scent of bergamot essential oil based on the changes in SSS before and after the intervention.
Evaluate the effect of extending the daily study time due to the scent of bergamot essential oil based on the changes before and after the intervention.
Evaluate the effect of extending the study time in the self-study room due to the scent of bergamot essential oil based on the changes before and after the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention group: Study at a desk with an aromastone with bergamot essential oil dripped onto it from three days before the exam to the day before the exam.
Interventions/Control_2
Control group: Study at a desk with an aromastone with water dripped onto it from three days before the exam to the day before the exam.
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
| 28 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who received a sufficient explanation about the purpose and contents of this research, had the ability to consent, participated voluntarily, and agreed to participate in writing.
Key exclusion criteria
(1) Individuals who refuse to participate in the study of their own will
(2) Individuals who cannot distinguish scents
(3) Individuals who dislike the scent of the aroma used
(4) Individuals who regularly practice aromatherapy
(5) Individuals with chronic illnesses who regularly visit medical institutions
(6) Individuals deemed unsuitable by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Division of Applied Pharmaceutical Education and Research
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
n-wakui@hoshi.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Division of Applied Pharmaceutical Education and Research
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
Homepage URL
n-wakui@hoshi.ac.jp
Sponsor or person
Institute
Hoshi University
Institute
Department
Personal name
Funding Source
Organization
Hoshi 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
Hoshi University
Address
142-8501, 2-4-41 Ebara, Shinagawa-ku, Tokyo
Tel
03-3786-1011
y-hashiguchi@hoshi.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
| 2024 | Year | 07 | Month | 10 | 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
| 2024 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 10 | Day |
Last modified on
| 2024 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062747
