UMIN-CTR Clinical Trial

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	Completed
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	2022 Year 04 Month 30 Day
Date analysis concluded	2022 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date	2022 Year 01 Month 07 Day
Last modified on	2022 Year 07 Month 15 Day

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