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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000031663
Receipt No. R000036157
Scientific Title Evaluation of effectiveness of End of Life simulation for undergraduate nursing students-Randomized controlled trial-
Date of disclosure of the study information 2018/03/10
Last modified on 2018/09/18

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Basic information
Public title Evaluation of effectiveness of End of Life simulation for undergraduate nursing students-Randomized controlled trial-
Acronym Evaluation of EOL care simulation
Scientific Title Evaluation of effectiveness of End of Life simulation for undergraduate nursing students-Randomized controlled trial-
Scientific Title:Acronym 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
1st name
Middle name
Last name Tomoko Tamaki
Organization Mukogawa Womans university
Division name School of nursing
Zip code
Address 6-46 Ikebiraki cho Nishinomiya City Hyogo
TEL 0798-39-9005
Email tomo1105@mukogawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Tamaki
Organization Mukogawa Womans university
Division name School of nursing
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2017 Year 10 Month 29 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000036157

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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