UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018585
Receipt number R000021511
Scientific Title The value of the relaxation effect of the foot bath using physiological and subjective indicator
Date of disclosure of the study information 2015/08/07
Last modified on 2015/08/07 12:11:49

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Basic information

Public title

The value of the relaxation effect of the foot bath using physiological and subjective indicator

Acronym

The value of the relaxation effect of the foot bath using physiological and subjective indicator

Scientific Title

The value of the relaxation effect of the foot bath using physiological and subjective indicator

Scientific Title:Acronym

The value of the relaxation effect of the foot bath using physiological and subjective indicator

Region

Japan


Condition

Condition

healthy volunteers

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this research is to make it clear which degree effect foot bathing using an aroma has on relaxation of body-like and a psychological stress.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Measurement items are the degree of the awareness stress, the heart rate, the blood pressure and saliva amylase.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Foot bathing

Interventions/Control_2

Foot bathing with aroma

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

22 years-old >=

Gender

Female

Key inclusion criteria

health volunteers

Key exclusion criteria

An exclusion object doesn't possess a basic disease and allergy to fruits for skin trouble, high blood pressure, a circulator disease and diabetes.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name emi matsuuura

Organization

Nagasaki University

Division name

Graduate School of Biomedical Sciences

Zip code


Address

1-7-1 Sakamoto Nagasaki

TEL

095-819-7924

Email

emimatsu@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name emi matsuuura

Organization

Nagasaki University

Division name

Graduate School of Biomedical Sciences

Zip code


Address

1-7-1 Sakamoto Nagasaki

TEL

095-819-7924

Homepage URL


Email

emimatsu@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

Nagasaki 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

2015 Year 08 Month 07 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

2015 Year 07 Month 21 Day

Date of IRB


Anticipated trial start date

2015 Year 07 Month 21 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

2015 Year 08 Month 07 Day

Last modified on

2015 Year 08 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021511


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name