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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030380
Receipt No. 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

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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
Email 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
Email tofujii-tky@umin.net

Sponsor
Institute Kyoto University
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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