UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042689
Receipt number R000048678
Scientific Title Stress situation survey and psychological support for hospital staff related to the new coronavirus
Date of disclosure of the study information 2020/12/10
Last modified on 2022/01/07 17:08:28

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Basic information

Public title

Stress situation survey and psychological support for hospital staff related to the new coronavirus

Acronym

Stress situation survey for hospital staff related to the new coronavirus

Scientific Title

Stress situation survey and psychological support for hospital staff related to the new coronavirus

Scientific Title:Acronym

Stress situation survey for hospital staff related to the new coronavirus

Region

Japan


Condition

Condition

Anxiety disorder, depression, fear of the new coronavirus

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

When the coronavirus infection spreads, all hospital staff will be screened for stress status using the K-6 questionnaire on the Web, and high-scoring people will be given a lecture on stress care via the Web.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Psychological stress response (K6), Currently 4 weeks later, 8 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

Audio slides for stress care under the prevalence of new coronavirus infections will be provided.

Interventions/Control_2

A brief pamphlet for stress care under the prevalence of new coronavirus infections will be provided.

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

1Nagasaki University Hospital staff
2People with internet environment

Key exclusion criteria

nothing

Target sample size

800


Research contact person

Name of lead principal investigator

1st name Hirohisa
Middle name
Last name Kinoshita

Organization

Nagasaki University

Division name

Center for Health and Community Medicine

Zip code

852-8521

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

Center for Health and Community Medicine

Zip code

852-8521

Address

1-14 Bunkyou,Nagasaki,852-8521,Japan

TEL

095-819-2212

Homepage URL


Email

nus-kino@nagasaki-u.ac.jp


Sponsor or person

Institute

Center for Health and Community Medicine Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

Center for Health and Community Medicine 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

1-12-4,Sakamoto,Nagasaki,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

2020 Year 12 Month 10 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

2020 Year 11 Month 20 Day

Date of IRB

2020 Year 11 Month 24 Day

Anticipated trial start date

2020 Year 12 Month 14 Day

Last follow-up date

2021 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

2020 Year 12 Month 08 Day

Last modified on

2022 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048678


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name