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

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 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)

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name