UMIN-CTR Clinical Trial

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
Institute	Medical corporation Keisenkai Seseragi Hospital
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049657