UMIN-CTR Clinical Trial

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
Name of lead principal investigator	1st name Masaaki Middle name Last name Ishikawa
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of Otolaryngology Head and Neck
Zip code	660-8550
Address	Hypo prefecture Amagasaki city higashinannba cho 2 17-77
TEL	0664807000
Email	m_ishikawa@ent.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Masaaki Middle name Last name Ishikawa
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Department of Otolaryngology Head and Neck
Zip code	660-8550
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	The Research Ethics Committee of Hyogo Prefectural Amagasaki General Medical Center
Address	Hypo prefecture Amagasaki city higashinannba cho 2 17-77
Tel	06-6480-7000
Email	aimaruko@gmail.com

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	Completed
Date of protocol fixation	2018 Year 10 Month 01 Day
Date of IRB	2018 Year 05 Month 28 Day
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	2021 Year 03 Month 05 Day

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