UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041940
Receipt number R000047867
Scientific Title The Effects of "Workation" at ONSEN
Date of disclosure of the study information 2020/09/30
Last modified on 2020/09/29 20:40:12

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Basic information

Public title

The Effects of "Workation" at ONSEN

Acronym

"Workation" at ONSEN

Scientific Title

The Effects of "Workation" at ONSEN

Scientific Title:Acronym

"Workation" at ONSEN

Region

Japan


Condition

Condition

healthy volunteers over 20y.o

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Psychosomatic Internal Medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of 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


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 4 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

120


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

1030027

Address

3-1-4 Nihonbshi Chuo Tokyo Japan

TEL

+81-3-5290-1621

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

1030027

Address

3-1-4 Nihonbshi Chuo Tokyo Japan

TEL

+81-5290-1621

Homepage URL


Email

ygoto@jph-ri.or.jp


Sponsor or person

Institute

Japan Health & Research Institute

Institute

Department

Personal name



Funding Source

Organization

Taketa City, BIGLOBE, TOJI-GURASHI

Organization

Division

Category of Funding Organization

Other

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 Nihonbashi Chuo Tokyo Japan

Tel

+81-5290-1621

Email

info@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 09 Month 30 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 09 Month 25 Day

Date of IRB

2020 Year 09 Month 28 Day

Anticipated trial start date

2020 Year 09 Month 29 Day

Last follow-up date

2022 Year 03 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 09 Month 29 Day

Last modified on

2020 Year 09 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047867


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name