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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028504
Receipt No. 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 2017/08/02

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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
Middle name
Last name Naoko Miyajima
Organization Faculty of Health Sciences, Hokkaido University
Division name Fundamental Nursing
Zip code
Address Kita12, Nishi5, Kita-ku, Sapporo, Hokkaido 060-0812, Japan
TEL 011-716-2111
Email miyajima@hs.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoko Miyajima
Organization Faculty of Health Sciences, Hokkaido University
Division name Fundamental Nursing
Zip code
Address Kita12, Nishi5, Kita-ku, Sapporo, Hokkaido 060-0812, Japan
TEL 011-716-2111
Homepage URL
Email miyajima@hs.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
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
2017 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032623

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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