UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028504 |
|---|---|
| Receipt number | R000032623 |
| Scientific Title | A comparison of the relaxation effects of an essential oil diffuser with a foot bath containing essential oil |
| Date of disclosure of the study information | 2017/08/03 |
| Last modified on | 2022/02/09 16:41:41 |
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Basic information
Public title
A comparison of the relaxation effects of an essential oil diffuser with a foot bath containing essential oil
Acronym
A comparison of the relaxation effects of an essential oil diffuser with a foot bath containing essential oil
Scientific Title
A comparison of the relaxation effects of an essential oil diffuser with a foot bath containing essential oil
Scientific Title:Acronym
A comparison of the relaxation effects of an essential oil diffuser with a foot bath containing essential oil
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will measure and compare the relaxation effects of an essential oil diffuser with the foot bath containing an essential oil.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will investigate each participant's heart rate,brain waves and anxiety state during each method.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
All subjects will have an essential oil diffuser for 10 minutes.
Interventions/Control_2
All subjects will have a foot bath containing essential oil (diffuse) for 10 minutes.
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All subjects are assumed to have no skin diseases, no allergies to aroma oil, no olfactory problems.
Key exclusion criteria
People with skin disorders, those who are allergic to aroma oil, those with olfactory problems will be excluded.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Miyajima |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
0600812
Address
Kita12, Nishi5, Kita-ku, Sapporo, Hokkaido
TEL
011-716-3327
miyajima@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Miyajima |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
0600812
Address
Kita12, Nishi5, Kita-ku, Sapporo, Hokkaido
TEL
011-716-3327
Homepage URL
miyajima@hs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido 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
Faculty of Health Sciences, Hokkaido University
Address
Kita12, Nishi5, Kita-ku, Sapporo, Hokkaido
Tel
011-706-3327
miyajima@hs.hokudai.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
| 2017 | Year | 08 | Month | 03 | 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
| 2017 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 11 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 02 | Day |
Last modified on
| 2022 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032623
