UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of effectiveness of End of Life simulation for undergraduate nursing students-Randomized controlled trial-
Title of the study (Brief title)	Evaluation of EOL care simulation
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to evaluate the effectiveness of the developed EOL simulation scenario for baccalaureate nursing students by randomized controlled study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	EOL care skill using Objective Structured Clinical Evaluation
Key secondary outcomes	Knowledge of EOL care Self-confidence about EOL care

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	The simulation group completed the EOL care simulation as an additional course(1hour).
Interventions/Control_2	The control group followed the usual nursing curriculum.
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	Eligible students(1)were undergraduate nursing students who achieved all credits in adult nursing specifics,(2)agreed to participate in the study.
Key exclusion criteria	Students who do not expect to participate in the study.
Target sample size	20

Research contact person
Name of lead principal investigator	Tomoko Tamaki
Organization	Mukogawa Womans university
Division name	School of nursing
Address	6-46 Ikebiraki cho Nishinomiya City Hyogo
TEL	0798-39-9005
Email	tomo1105@mukogawa-u.ac.jp

Public contact
Name of contact person	Tomoko Tamaki
Organization	Mukogawa Womans university
Division name	School of nursing
Address	6-46 Ikebiraki cho Nishinomiya City Hyogo
TEL	0798-39-9005
Homepage URL
Email	tomo1105@mukogawa-u.ac.jp

Sponsor
Institute	Mukogawa Womans university
Institute
Department

Funding Source
Organization	MEXT/JSPS KAKENHI Grants-in-Aid for Sceintific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	武庫川女子大学 三重大学

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 10 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 10 Month 29 Day
Anticipated trial start date	2018 Year 03 Month 09 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 03 Month 10 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036157