UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038615 |
|---|---|
| Receipt number | 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 20:14:27 |
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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
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
seninoue@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044012
