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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046587
Receipt No. R000053143
Scientific Title Survey of stress status and psychological support for hospital staff related to the new coronavirus, 2nd
Date of disclosure of the study information 2022/01/08
Last modified on 2022/01/07

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Basic information
Public title Survey of stress status and psychological support for hospital staff related to the new coronavirus, 2nd
Acronym Survey of stress status for hospital staff related to the new coronavirus, 2nd
Scientific Title Survey of stress status and psychological support for hospital staff related to the new coronavirus, 2nd
Scientific Title:Acronym Survey of stress status for hospital staff related to the new coronavirus, 2nd
Region
Japan

Condition
Condition Anxiety disorders, depression, fear of new coronavirus
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In response to the spread of coronavirus infection, all hospital employees will be screened for stress using a web-based K-6 questionnaire.
Basic objectives2 Others
Basic objectives -Others During the first survey, two types of randomly assigned stress care materials will be provided, and during the second survey, the effectiveness of the materials will be tested.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Psychological stress response (K6),Currently, 4 weeks later.
Key secondary outcomes Drinking frequency

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Provide an automated slide show with audio on how to cope with stress in a situation where a new coronavirus infection is spreading.
Interventions/Control_2 Provide a brief pamphlet on how to cope with stress in a situation where a new coronavirus infection is spreading.
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 1) Nagasaki University Hospital staff
2) People with internet access
Key exclusion criteria nothing
Target sample size 480

Research contact person
Name of lead principal investigator
1st name Hirohisa
Middle name
Last name Kinoshita
Organization Nagasaki University
Division name health center
Zip code 8528521
Address 1-14 Bunkyou,Nagasaki,852-8521,Japan
TEL 095-819-2212
Email nus-kino@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Hirohisa
Middle name
Last name Kinoshita
Organization Nagasaki University
Division name health center
Zip code 8528521
Address 1-14 Bunkyou,Nagasaki,852-8521,Japan
TEL 095-819-2212
Homepage URL
Email nus-kino@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Health Center
Institute
Department

Funding Source
Organization Nagasaki University Health Center
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 Ethics Committee of Nagasaki University Graduate School of Biomedical Sciences
Address 1-12-24, Sakamoto,Nasaki,852-8523,Japan
Tel 095-819-7198
Email miyaji195@nagasaki-u.ac.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 01 Month 08 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
2021 Year 12 Month 20 Day
Date of IRB
2021 Year 12 Month 24 Day
Anticipated trial start date
2022 Year 01 Month 17 Day
Last follow-up date
2022 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 01 Month 07 Day
Last modified on
2022 Year 01 Month 07 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053143

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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