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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033735
Receipt No. 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 2018/08/13

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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
Middle name
Last name Kosuke Maeda
Organization Tokyo Metropolitan University
Division name Graduate School of Human Health Sciences
Zip code
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
Middle name
Last name Kosuke Maeda
Organization Tokyo Metropolitan University
Division name Graduate School of Human Health Sciences
Zip code
Address 7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL 0338191211
Homepage URL
Email k-maeda@tmu.ac.jp

Sponsor
Institute Tokyo Metropolitan University
Institute
Department

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
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
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
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
2018 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 15 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
2018 Year 08 Month 13 Day
Last modified on
2018 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.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


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