UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of relaxing effects accmpanying bathing using cypress bathtub
Title of the study (Brief title)	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	Masahiro YAMAMOTO
Organization	Mie prefecture health and environment research institute
Division name	Department of hygienic sciences
Address	3684-11 Sakura-cho, Yokkaichi, Mie
TEL	059-329-3800
Email	hokan@pref.mie.jp

Public contact
Name of contact person	Yasunori MORI
Organization	Mie prefecture health and environment research institute
Division name	Department of hygienic sciences
Address	3684-11 Sakura-cho, Yokkaichi, Mie
TEL	059-329-3800
Homepage URL
Email	hokan@pref.mie.jp

Sponsor
Institute	Mie prefecture health and environment research institute
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024767