UMIN-CTR Clinical Trial

Basic information
Public title	The Effects of "ONSEN WORK"
Acronym	The Effects of "ONSEN WORK"
Scientific Title	The Effects of "ONSEN WORK"
Scientific Title:Acronym	The Effects of "ONSEN WORK"
Region	Japan

Condition
Condition	healthy volunteers over 20y.o
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Cardiology Surgery in general Endocrine surgery Dermatology Psychiatry Orthopedics Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of ONSEN WORK (Workation at ONSEN)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective health status
Key secondary outcomes	Accelerated photoplethysmography, Heart rate valiability, Salivary amylase, Sublingual temperature, Blood pressure, Physical function, Flexibility, Weight, Skin condition,,Nutritional balance, Intestinal environment,Work performance and ability

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Stay at ONSEN (from 1 to 30 nights) for workation. The worktime per a day is from 4 tp 8 hours
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 adluts over 20 y.o.
Key exclusion criteria	Those who have diagnosed with the condition that they should not take bathing
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Yasuaki Middle name Last name Goto
Organization	Japan Health & Research Institute
Division name	Research Department
Zip code	103-0027
Address	3-1-4 Nihonbshi Chuo Tokyo Japan
TEL	03-5290-1621
Email	ygoto@jph-ri.or.jp

Public contact
Name of contact person	1st name Yasuaki Middle name Last name Goto
Organization	Japan Health & Research Institute
Division name	Research Department
Zip code	103-0027
Address	3-1-4 Nihonbshi Chuo Tokyo Japan
TEL	03-5290-1621
Homepage URL
Email	ygoto@jph-ri.or.jp

Sponsor
Institute	Japan Health & Research Institute
Institute
Department

Funding Source
Organization	Japan Health & Research Institute
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japan Health & Research Institute
Address	3-1-4 Nihonbshi Chuo Tokyo Japan
Tel	03-5290-1621
Email	ygoto@jph-ri.or.jp

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	2020 Year 12 Month 12 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	Enrolling by invitation
Date of protocol fixation	2020 Year 12 Month 11 Day
Date of IRB	2020 Year 12 Month 11 Day
Anticipated trial start date	2020 Year 12 Month 13 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 12 Day
Last modified on	2020 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048781