UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043540
Receipt number R000049657
Scientific Title The impact of oral biography on nurses caring for dialysis patients-An initiative to turn "nursing that I cherish" into an oral biography
Date of disclosure of the study information 2021/03/07
Last modified on 2021/03/07 09:23:27

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Basic information

Public title

The impact of oral biography on nurses caring for dialysis patients-An initiative to turn "nursing that I cherish" into an oral biography

Acronym

The impact of oral biography on nurses caring for dialysis patients

Scientific Title

The impact of oral biography on nurses caring for dialysis patients-An initiative to turn "nursing that I cherish" into an oral biography

Scientific Title:Acronym

The impact of oral biography on nurses caring for dialysis patients

Region

Japan


Condition

Condition

Healthy person

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate how nurses who provide care to dialysis patients will be affected by changing "Nursing that I cherish" to oral biography.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Information on changes in feelings and behavior after oral biography

Key secondary outcomes



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

Interventor performs oral biography on a nurse providing care to a dialysis patient

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

A nurse or associate nurse providing care to a dialysis patient


Key exclusion criteria

Those who increase their mental burden by talking

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Makiko
Middle name
Last name Itaya

Organization

Medical corporation Keisenkai Seseragi Hospital

Division name

Nursing department

Zip code

3792211

Address

1-1399 Ichibacho, Isesaki City, Gunma

TEL

0270636363

Email

mkawase.seseragi@gmail.com


Public contact

Name of contact person

1st name Makiko
Middle name
Last name Itaya

Organization

Medical corporation Keisenkai Seseragi Hospital

Division name

Nursing department

Zip code

3792211

Address

1-1399 Ichibacho, Isesaki City, Gunma

TEL

0270636363

Homepage URL


Email

mkawase.seseragi@gmail.com


Sponsor or person

Institute

Medical corporation Keisenkai Seseragi Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Academy of Nephrology Nursing

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gunma University Medical and Health Research Involving Human Subjects

Address

3-39-15 Showamachi, Maebashi City, Gunma

Tel

027-220-8740

Email

hitotaisho-ciru@ml.gunma-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

2021 Year 03 Month 07 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

Enrolling by invitation

Date of protocol fixation

2021 Year 02 Month 26 Day

Date of IRB

2021 Year 02 Month 26 Day

Anticipated trial start date

2021 Year 03 Month 15 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 03 Month 07 Day

Last modified on

2021 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049657


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name