UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030380 |
|---|---|
| Receipt number | R000034683 |
| Scientific Title | Moral Distress in Japanese Critical Care Professionals: A Nation-wide mixed method study |
| Date of disclosure of the study information | 2017/12/13 |
| Last modified on | 2020/12/26 14:25:34 |
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Basic information
Public title
Moral Distress in Japanese Critical Care Professionals: A Nation-wide mixed method study
Acronym
Moral Distress Study in Japan
Scientific Title
Moral Distress in Japanese Critical Care Professionals: A Nation-wide mixed method study
Scientific Title:Acronym
Moral Distress Study in Japan
Region
| Japan |
Condition
Condition
critical care professionals in the intensive care unit
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe demographic characteristics of moral distress in Japanese critical care professionals.
Basic objectives2
Others
Basic objectives -Others
Descriptive epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Moral Distress score
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Critical care physicians and nurses in the Japanese ICUs
Key exclusion criteria
Residents or those who have worked in the ICU for less than one year.
Those who do not engage in clinical practice.
Those without consent to the study participation.
Those without consent to the study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Fujii |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
606-8501
Address
Yoshida Hon-machi, Sakyo-ku, Kyoto
TEL
075-753-2431
tofujii-tky@umin.net
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Fujii |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
606-8501
Address
Yoshida Hon-machi, Sakyo-ku, Kyoto
TEL
075-753-2431
Homepage URL
tofujii-tky@umin.net
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
The Fujiwara Memorial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2017 | Year | 12 | Month | 13 | Day |
Related information
URL releasing protocol
http://hi.med.kyoto-u.ac.jp/MDS.html
Publication of results
Unpublished
Result
URL related to results and publications
http://hi.med.kyoto-u.ac.jp/MDS.html
Number of participants that the trial has enrolled
1000
Results
Presented at the 46th Annual Meeting of the Japanese Society of Intensive Care Medicine.
Results date posted
| 2020 | Year | 12 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Presented at the 46th Annual Meeting of the Japanese Society of Intensive Care Medicine.
Participant flow
Presented at the 46th Annual Meeting of the Japanese Society of Intensive Care Medicine.
Adverse events
N/A
Outcome measures
Presented at the 46th Annual Meeting of the Japanese Society of Intensive Care Medicine.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A mixed method study based on a sequential explanatory design.
Moral distress will be measured by using the Moral Distress Scale.
Survey items in the scale are implemented according to the general cross-cultural adaptation process.
Management information
Registered date
| 2017 | Year | 12 | Month | 13 | Day |
Last modified on
| 2020 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034683
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
