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
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
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
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
