UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038615
Receipt No. R000044012
Scientific Title Does working circumstance affect caregiver's stress in intensive care units
Date of disclosure of the study information 2020/01/01
Last modified on 2019/11/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.