UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050044 |
|---|---|
| Receipt number | R000057009 |
| Scientific Title | Survey of stress status and psychological support for hospital staff related to the new coronavirus, 3rd. |
| Date of disclosure of the study information | 2023/01/16 |
| Last modified on | 2023/01/15 14:50:51 |
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Basic information
Public title
Survey of stress status and psychological support for hospital staff related to the new coronavirus, 3rd.
Acronym
Survey of stress status and psychological support for hospital staff related to the new coronavirus, 3rd.
Scientific Title
Survey of stress status and psychological support for hospital staff related to the new coronavirus, 3rd.
Scientific Title:Acronym
Survey of stress status and psychological support for hospital staff related to the new coronavirus, 3rd.
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 new coronavirus infection, all hospital employees will be screened for stress using a web-based k-6 questionnaire.
Basic objectives2
Others
Basic objectives -Others
Two randomly assigned stress care materials (mental care for post-coronary symptoms) will be provided during the first survey, and their effectiveness will be tested during the second survey.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological stress reaction (K-6) Present, 4 weeks later
Key secondary outcomes
Frequency of drinking, Frequency of eating out, Frequency of wearing a mask on a daily life
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 automated slides with audio on how to provide mental care for post-neoplastic coronary symptoms.
Interventions/Control_2
Provide a brief brochure on how to provide mental care for post-neoplastic coronavirus symptoms.
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 Persons with internet access
Key exclusion criteria
nothing in particular
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
1-14Bunkyou,Nagasaki,852-8521,Japan
TEL
0958192212
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
1-14Bunkyou,Nagasaki,852-8521,Japan
TEL
0958192212
Homepage URL
nus-kino@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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,Nagasaki,852-8523,Japan
Tel
095-819-7198
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
| 2023 | Year | 01 | Month | 16 | 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 | 12 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 01 | Month | 15 | Day |
Last modified on
| 2023 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057009
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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