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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035449
Receipt No. R000040388
Scientific Title Efficacy of foot bath on autonomic function
Date of disclosure of the study information 2019/01/06
Last modified on 2019/02/21

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Basic information
Public title Efficacy of foot bath on autonomic function
Acronym Efficacy of foot bath on autonomic function
Scientific Title Efficacy of foot bath on autonomic function
Scientific Title:Acronym Efficacy of foot bath on autonomic function
Region
Japan

Condition
Condition Healthy adults underwent foot bath
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of foot bath on heart rate variability and pupil light reflex in healthy adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Heart rate variability and pupil light reflex parameters
Key secondary outcomes Efficacy of different stimulus intensity of pupil light reflex on pupil light reflex parameters

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy adults
Key exclusion criteria Smokers
Alcoholic
Obesity
Asthma with treatmens
Diabetes
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Masaaki Ishikawa
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Department of Otolaryngology Head and Neck
Zip code
Address Hypo prefecture Amagasaki city higashinannba cho 2 17-77
TEL 0664807000
Email m_ishikawa@ent.kuhp.kyoto-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Masaaki Ishikawa
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Department of Otolaryngology Head and Neck
Zip code
Address Hypo prefecture Amagasaki city higashinannba cho 2 17-77
TEL 0664807000
Homepage URL
Email m_ishikawa@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute Hyogo Prefectural Amagasaki General Medical Center
Institute
Department

Funding Source
Organization Japan health and research institute
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2019 Year 01 Month 06 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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study
Prospective cohort study
foot bath under 40 degrees for 15 mins, followed by
5 mins for hear rate variability measurements and 2 mins for pupil light reflex measurements
Preparing for 4 different stimulus intensity of pupil light reflex
POMS evaluation for mood alteration induced by foot bath
The aim of this study is to investigate heart rate variability and pupil light reflex parameters and criteria reflecting autonomic alteration induced by foot bath.

Management information
Registered date
2019 Year 01 Month 05 Day
Last modified on
2019 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040388

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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