UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041892 |
|---|---|
| Receipt number | 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 | 2022/03/27 10:25:00 |
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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
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
tanaka.cc@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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)
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
34
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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 17 | Day |
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
| 2021 | Year | 12 | Month | 03 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 03 | Day |
Date analysis concluded
| 2022 | Year | 01 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 24 | Day |
Last modified on
| 2022 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047813
