UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000034683