UMIN-CTR Clinical Trial

Basic information
Public title	Does working circumstance affect caregiver's stress in intensive care units
Acronym	Caregiver's stress in ICU
Scientific Title	Does working circumstance affect caregiver's stress in intensive care units
Scientific Title:Acronym	Caregiver's stress in ICU
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether working situation can affect caregiver's stress.
Basic objectives2	Others
Basic objectives -Others	None
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Saliva amylase activity,VAS
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	21 years-old <
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	ICU Nurses
Key exclusion criteria	None
Target sample size	120

Research contact person
Name of lead principal investigator	1st name SATOKI Middle name Last name INOUE
Organization	Nara Medical University
Division name	Anesthesiology and Intenive care
Zip code	6348521
Address	840 Shijo-cho Kashihara Nara Japan
TEL	0744463578
Email	seninoue@naramed-u.ac.jp

Public contact
Name of contact person	1st name SATOKI Middle name Last name INOUE
Organization	Nara Medical University
Division name	Anesthesiology and Intenive care
Zip code	6348521
Address	840 Shijo-cho Kashihara Nara Japan
TEL	0744223051
Homepage URL
Email	seninoue@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Keihanna Research Complex
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	Nara Medical University
Address	840 Shijo-cho Kashihara Nara
Tel	0744223051
Email	ino_rinri@naramed-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	奈良県立医科大学

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 01 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	2019 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Nothing particular

Management information
Registered date	2019 Year 11 Month 18 Day
Last modified on	2019 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044012

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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