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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name