UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021473 |
|---|---|
| Receipt number | R000024767 |
| Scientific Title | Examination of relaxing effects accmpanying bathing using cypress bathtub |
| Date of disclosure of the study information | 2016/03/15 |
| Last modified on | 2017/07/18 11:45:50 |
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Basic information
Public title
Examination of relaxing effects accmpanying bathing using cypress bathtub
Acronym
Examination of relaxing effects accmpanying bathing using cypress bathtub
Scientific Title
Examination of relaxing effects accmpanying bathing using cypress bathtub
Scientific Title:Acronym
Examination of relaxing effects accmpanying bathing using cypress bathtub
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is examination of relaxing effects accmpanying bathing using bathtub made from cypress of Mie prefecture origin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary cortisol, Mood check list short form 2(MCL-S.2), Visual analog scale(VAS), and Holter monitor just before-and-after interventional bathing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
After giving their informed consent, subjects have a bath with modular bath once.
Rest(for a period of about 60 minutes), exercise(for a period of 5 minutes), rest(for a period of about 10 minutes), bathing with cypress bathtub(for a period of 15 minutes), and rest(for a period of about 60 minutes).
After a month as wash-out period, subjects have a bath with cypress bathtub once.
Rest(for a period of about 60 minutes), exercise(for a period of 5 minutes), rest(for a period of about 10 minutes), bathing with modular bathtub(for a period of 15 minutes), and rest(for a period of about 60 minutes).
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy male and female
Key exclusion criteria
Not have serious underlying disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro YAMAMOTO |
Organization
Mie prefecture health and environment research institute
Division name
Department of hygienic sciences
Zip code
Address
3684-11 Sakura-cho, Yokkaichi, Mie
TEL
059-329-3800
hokan@pref.mie.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori MORI |
Organization
Mie prefecture health and environment research institute
Division name
Department of hygienic sciences
Zip code
Address
3684-11 Sakura-cho, Yokkaichi, Mie
TEL
059-329-3800
Homepage URL
hokan@pref.mie.jp
Sponsor or person
Institute
Mie prefecture health and environment research institute
Institute
Department
Personal name
Funding Source
Organization
Mie prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 05 | 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
| 2016 | Year | 03 | Month | 15 | Day |
Last modified on
| 2017 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024767
