UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046709 |
|---|---|
| Receipt number | R000053159 |
| Scientific Title | A crossover study to evaluate the effectiveness of bergamot essential oil on sleep quality and stress |
| Date of disclosure of the study information | 2022/01/25 |
| Last modified on | 2023/07/27 20:33:05 |
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Basic information
Public title
A crossover study to evaluate the effectiveness of bergamot essential oil on sleep quality and stress
Acronym
A crossover study to evaluate the effectiveness of bergamot essential oil on sleep quality and stress
Scientific Title
A crossover study to evaluate the effectiveness of bergamot essential oil on sleep quality and stress
Scientific Title:Acronym
A crossover study to evaluate the effectiveness of bergamot essential oil on sleep quality and stress
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effectiveness of bergamot essential oil on reducing psychological stress as measured by the quality of sleep, awakening, and levels of anxiety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assess sleep quality and morning awakening using the OSA sleep inventory MA version
Key secondary outcomes
Assess stress and sleep using DASS-21, Subjective Happiness Scale, and VAS
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention group. Subjects in the study group will keep a towel at the bedside that is sprayed with bergamot essential oil. They will sleep and wake up next to the towel for 5 consecutive days.
Interventions/Control_2
Control group. Subjects in the control group will keep a towel at the bedside that is sprayed with an odorless liquid. They will sleep and wake up next to the towel for 5 consecutive days.
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
| 20 | years-old | <= |
Age-upper limit
| 28 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who have received sufficient explanation about the purpose and contents of this research, have the ability to consent, volunteered voluntarily after fully understanding, and agreed to participate in writing.
Key exclusion criteria
Volunteers will be excluded from study participation if they:
1) refuse to participate in the study;
2) cannot detect the scent of bergamot essential oil;
3) sensitive the aroma of bergamot oil used in the study;
4) are using sleep medication;
5) have hypertension, seizure disorders, or other chronic diseases;
6) have hypersensitivity to alcohol-based products;
7) test positive for allergic reactions at study registration; or
8) are deemed ineligible by principal investigator for other reasons not listed above.
Target sample size
44
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
Practical Education and Research Division
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
somu@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
| 2022 | Year | 01 | Month | 25 | 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
48
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
| 2021 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 27 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 27 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 27 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 24 | Day |
Last modified on
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053159
