UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047692 |
|---|---|
| Receipt number | 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 | 2023/03/03 09:35:48 |
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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
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
hokan@pref.mie.lg.jp
Sponsor or person
Institute
Academic Committee, Japanese society of Balneology, Climatology and Physical Medicine
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
754
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
| 2022 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 09 | Day |
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
| 2023 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054374
