UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033735
Receipt number R000038467
Scientific Title Physio-psychological changes of different thermal stimulation to the feet by footbath -Changes in cerebral blood flow dynamics, autonomic nerve activity, skin surface temperature, body temperature and mood-
Date of disclosure of the study information 2018/09/01
Last modified on 2020/02/13 09:19:58

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Physio-psychological changes of different thermal stimulation to the feet by footbath -Changes in cerebral blood flow dynamics, autonomic nerve activity, skin surface temperature, body temperature and mood-

Acronym

Physio-psychological changes of different thermal stimulation to the feet by footbath

Scientific Title

Physio-psychological changes of different thermal stimulation to the feet by footbath -Changes in cerebral blood flow dynamics, autonomic nerve activity, skin surface temperature, body temperature and mood-

Scientific Title:Acronym

Physio-psychological changes of different thermal stimulation to the feet by footbath

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of thermal stimulation to the feet by different temperatures on cerebral blood flow dynamics.

Basic objectives2

Others

Basic objectives -Others

To clarify the physio-psychological changes of different thermal stimulation to the feet by footbath.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Measure the cerebral blood flow dynamics of the prefrontal using near infrared spectroscopy. Measure while footbathing and after footbath finish.

Key secondary outcomes

Measure autonomic nerve activity, skin surface temperature, body temperature, mood at the same time.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Control
Perform footbath for 10 minutes(one time).
The water temperature of the footbath is the skin surface temperature of the lower extremity(between 29 to 31 degrees).

Interventions/Control_2

Intervention1
Perform footbath for 10 minutes(one time).
The water temperature of the footbath is 8 degrees hotter than the skin surface temperature of the lower extremity(between 37 to 39 degrees).

Interventions/Control_3

Intervention2
Perform footbath for 10 minutes(one time).
The water temperature of the footbath is 10 degrees hotter than the skin surface temperature of the lower extremity(between 39 to 41 degrees).

Interventions/Control_4

Intervention3
Perform footbath for 10 minutes(one time).
The water temperature of the footbath is 12 degrees hotter than the skin surface temperature of the lower extremity(between 41 to 43 degrees).

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

60 years-old >

Gender

Male and Female

Key inclusion criteria

Invite research targets by public invitation.
To eliminate the effects of gender, the same number of males and females participates.
In the case of females, the basal body temperature is stabilized, and the day when autonomic nerve fluctuation due to hormonal balance is small(follicular phase).
To eliminate the effects of the dominant cerebral hemisphere, only a right-handed person participates.

Key exclusion criteria

Persons who have a history of circulatory disease or skin abnormality symptoms or coldness are excluded. Also exclude those with claustrophobia or those with a history of discomfort due to MRI.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Kosuke
Middle name
Last name Maeda

Organization

Tokyo Metropolitan University

Division name

Graduate School of Human Health Sciences

Zip code

1168551

Address

7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan

TEL

0338191211

Email

k-maeda@tmu.ac.jp


Public contact

Name of contact person

1st name Kosuke
Middle name
Last name Maeda

Organization

Tokyo Metropolitan University

Division name

Graduate School of Human Health Sciences

Zip code

1168551

Address

7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan

TEL

0338191211

Homepage URL


Email

k-maeda@tmu.ac.jp


Sponsor or person

Institute

Tokyo Metropolitan University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tokyo Metropolitan University

Address

7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan

Tel

0338191211

Email

medaka_0305_mk@yahoo.co.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

2018 Year 09 Month 01 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

22

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

No longer recruiting

Date of protocol fixation

2018 Year 09 Month 01 Day

Date of IRB

2018 Year 08 Month 24 Day

Anticipated trial start date

2018 Year 09 Month 15 Day

Last follow-up date

2020 Year 01 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 13 Day

Last modified on

2020 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038467


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name