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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047692
Receipt No. R000054374
Scientific Title Changes in subjective health and behavioral restrictions (including hot spring bathing) of medical workers and care staff under the influence of COVID-19 (National survey)
Date of disclosure of the study information 2022/05/20
Last modified on 2022/05/09

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Basic information
Public title Changes in subjective health and behavioral restrictions (including hot spring bathing) of medical workers and care staff under the influence of COVID-19 (National survey)
Acronym Changes in subjective health and behavioral restrictions of medical workers under the influence of COVID-19 (National survey)
Scientific Title Changes in subjective health and behavioral restrictions (including hot spring bathing) of medical workers and care staff under the influence of COVID-19 (National survey)
Scientific Title:Acronym Changes in subjective health and behavioral restrictions of medical workers under the influence of COVID-19 (National survey)
Region
Japan

Condition
Condition Healthy subject
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between change in subjective health and behavioral restriction (including hot spring bathing) in medical workers and care staff nationwide under the influence of COVID-19
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Score of subjective health feeling
Key secondary outcomes

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
18 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Medical workers and care staff
Key exclusion criteria Nothing
Target sample size 20000

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name NAKAMURA
Organization Oyamada Memorial Spa Hospital
Division name Internal medicine
Zip code 512-1111
Address Yamada 5538-1, Yokkaichi, Mie, Japan
TEL 059-328-1260
Email info@syutaikai.jp

Public contact
Name of contact person
1st name Yasunori
Middle name
Last name MORI
Organization Mie Prefecture Health and Environment Research Institute
Division name Hygiene Research Division
Zip code 512-1211
Address Sakura 3684-11, Yokkaichi, Mie, Japan
TEL 059-329-3800
Homepage URL
Email hokan@pref.mie.lg.jp

Sponsor
Institute Academic Committee, Japanese society of Balneology, Climatology and Physical Medicine
Institute
Department

Funding Source
Organization Academic Committee, Japanese society of Balneology, Climatology and Physical Medicine
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 The Ethic Board of Syutaikai
Address Yamada 5538-1, Yokkaichi, Mie, Japan
Tel 059-328-1260
Email info@syutaikai.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
2022 Year 05 Month 20 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 Preinitiation
Date of protocol fixation
2022 Year 04 Month 08 Day
Date of IRB
Anticipated trial start date
2022 Year 06 Month 11 Day
Last follow-up date
2023 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Authors:
Dr.Takeshi NAKAMURA, Dr.Yasunori MORI, Dr. Takahiko HORIUCHI, Dr.Koichiro OHMURA, Dr.Shunji SAKAGUCHI, Dr.Satoru YAMAGUCHI, Dr.Hiroharu KAMIOKA

PECOS:
P:Medical workers and care staff nationwide
E:Behavioral restrictions (including hot spring bathing) under the influence of COVID-19
C:Before the influence of COVID-19 (Retrospective method)
O:Changes of subjective health score
S:Questionnaire survey on web

Management information
Registered date
2022 Year 05 Month 09 Day
Last modified on
2022 Year 05 Month 09 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054374

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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