UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021183 |
|---|---|
| Receipt number | R000024405 |
| Scientific Title | The development, and evaluation of the end-of-life simulation program for baccalaureate nursing students: Randomized controlled trial |
| Date of disclosure of the study information | 2016/02/24 |
| Last modified on | 2018/09/18 11:28:07 |
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Basic information
Public title
The development, and evaluation of the end-of-life simulation program for baccalaureate nursing students: Randomized controlled trial
Acronym
EOL Simulation Program
Scientific Title
The development, and evaluation of the end-of-life simulation program for baccalaureate nursing students: Randomized controlled trial
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tomoko Tamaki |
Organization
Mukogawa womens university
Division name
School of nursing
Zip code
Address
6-46 Ikebiraki Nishinomiya-city
TEL
0798-39-9030
tomo1105@mukogawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Tamaki |
Organization
Mukogawa womens university
Division name
School of nursing
Zip code
Address
6-46 Ikebiraki Nishinomiya-city
TEL
0798-39-9030
Homepage URL
tomo1105@mukogawa-u.ac.jp
Sponsor or person
Institute
Mukogawa womens university
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024405
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
