UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035449 |
|---|---|
| Receipt number | R000040388 |
| Scientific Title | Efficacy of foot bath on autonomic function |
| Date of disclosure of the study information | 2019/01/06 |
| Last modified on | 2021/03/05 09:29:49 |
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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
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
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
m_ishikawa@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Hyogo Prefectural Amagasaki General Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040388
