UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The development, and evaluation of the end-of-life simulation program for baccalaureate nursing students: Randomized controlled trial
Title of the study (Brief title)	EOL Simulation Program
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to develop a high fidelity end of life simulation for baccalaureate nursing program and to evaluate the effect compared with control group in increasing clinical skill, knowledge, flow experience, self efficacy and self-esteem.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Clinical competence of end of life care
Key secondary outcomes	Confidence, knowledge, resilience, flow-experience and self-efficacy

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
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	End of life care simulation (1hour, single session)
Interventions/Control_2	Control
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Third year nursing students, who are interested in participating this program and have finished the following all of course; Adult nursing course 1, 2 and 3.
Key exclusion criteria	Students who do not join in this program. Students who can not participate in the given day for simulation.
Target sample size	40

Research contact person
Name of lead principal investigator	Tomoko Tamaki
Organization	Mukogawa womens university
Division name	School of nursing
Address	6-46 Ikebiraki Nishinomiya-city
TEL	0798-39-9030
Email	tomo1105@mukogawa-u.ac.jp

Public contact
Name of contact person	Tomoko Tamaki
Organization	Mukogawa womens university
Division name	School of nursing
Address	6-46 Ikebiraki Nishinomiya-city
TEL	0798-39-9030
Homepage URL
Email	tomo1105@mukogawa-u.ac.jp

Sponsor
Institute	Mukogawa womens university
Institute
Department

Funding Source
Organization	Grants in aid for science research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 24 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 01 Month 12 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 05 Month 31 Day
Date trial data considered complete	2017 Year 05 Month 31 Day
Date analysis concluded	2017 Year 05 Month 31 Day

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

Management information
Registered date	2016 Year 02 Month 24 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=R000024405