UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056219 |
|---|---|
| Receipt number | R000064133 |
| Scientific Title | Effectiveness of End-of-Life care simulation for multiple nursing students |
| Date of disclosure of the study information | 2024/11/20 |
| Last modified on | 2024/11/20 18:52:20 |
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Basic information
Public title
Effectiveness of End-of-Life care simulation for multiple nursing students
Acronym
Effectiveness of End-of-Life care simulation for multiple nursing students
Scientific Title
Effectiveness of End-of-Life care simulation for multiple nursing students
Scientific Title:Acronym
End-of-Life care simulation
Region
| Japan |
Condition
Condition
Adult nursing students
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the learning effects of EOL care simulation that can be participated in by a large number of people (approximately 20 to 30 students).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
knowledge check on end-of-life care (10-point scale)
Key secondary outcomes
Skills: OSCE (physical assessment of EOL care: 8-point scale and psychological care: 15-point scale)
Confidence: subjective assessment (5-point Likert scale)
Resilience scale
Flow experience checklist
Reflection form (free-text)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver | Other |
Interventions/Control_1
One 90-minute End-of0life care simulation training session
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
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Students who have acquired all the credits for the theory and principles of adult nursing.
Key exclusion criteria
Students who have not complete the measurement of evaluation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Tamaki |
Organization
Shiga university of medical science
Division name
Fundamental nursing
Zip code
520-2192
Address
Seta Tukinowacho, Otsu, Shiga, Japan
TEL
+81-77-748-2083
tamaki@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Tamaki |
Organization
Shiga university of medical science
Division name
Fundamental nursing
Zip code
520-192
Address
Seta Tukinowacho, Otsu, Shiga, Japan
TEL
+81-77-748-2083
Homepage URL
tamaki@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga university of medical science
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Grants-in-Aid for Scientific Research KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science Research Ethics Committee
Address
Seta Tukinowacho, Otsu, Shiga, Japan
Tel
+81-77-748-2083
rrb@belle.shiga-med.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
| 2024 | Year | 11 | Month | 20 | 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
19
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 11 | Month | 20 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064133
