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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041892
Receipt No. R000047813
Scientific Title Development of support program for moral distress in acute care nurse: a preliminary study
Date of disclosure of the study information 2020/11/30
Last modified on 2021/09/25

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Basic information
Public title Development of support program for moral distress in acute care nurse: a preliminary study
Acronym Development of support program for moral distress in acute care nurse: a preliminary study
Scientific Title Development of support program for moral distress in acute care nurse: a preliminary study
Scientific Title:Acronym Development of support program for moral distress in acute care nurse: a preliminary study
Region
Japan

Condition
Condition Moral distress
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether a support program using the Moral case deliberation (MCD) method is effective in reducing moral distress of nurses working in critical care.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcome is the Measurement of Moral Distress - Healthcare Professionals (MMD-HP), a measure of moral distress.
Key secondary outcomes The secondary outcomes are the Euro-MCD 2.0 Japanese version scale, which measures the effect of MCD, and the intention to leave the job (Yes / No), which is the main adverse effect of moral distress.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Using the Moral case deliberation (MCD) methodology, which is said to be effective in reducing moral distress, MCD is performed multiple times about 3 to 4 months, especially for nurses in the intensive care unit, who are considered to be severe in moral distress.
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
22 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Nurses working in critical care
Key exclusion criteria Nurses who cannot speak Japanese
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Tanaka
Organization Graduate school of Health Sciences
Tokyo Medical and Dental University
Division name Critical and Invasive - Palliative Care Nursing
Zip code 113-8510
Address 1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL 03-3813-5351
Email tanaka.cc@tmd.ac.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Tanaka
Organization Graduate school of Health Sciences Tokyo Medical and Dental University
Division name Critical and Invasive - Palliative Care Nursing
Zip code 113-8510
Address 1-5-45 Yushima Bunkyo-ku Tokyo Japan
TEL 03-3813-5351
Homepage URL
Email tanaka.cc@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Committees of the Tokyo Medical and Dental University
Address 1-5-45 Yushima Bunkyo-ku Tokyo Japan
Tel 03-3813-6111(5096,7102)
Email syomu1.adm@tmd.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 東京医科歯科大学附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 30 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
2020 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2021 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 24 Day
Last modified on
2021 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047813

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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