UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052817 |
|---|---|
| Receipt number | R000060267 |
| Scientific Title | Evaluation of Simulation Education Using Realistic Infant Models |
| Date of disclosure of the study information | 2023/11/20 |
| Last modified on | 2024/05/16 11:50:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of Simulation Education Using Realistic Infant Models
Acronym
Evaluation of Simulation Education Using Realistic Infant Models
Scientific Title
Evaluation of Simulation Education Using Realistic Infant Models
Scientific Title:Acronym
Evaluation of Simulation Education Using Realistic Infant Models
Region
| Japan |
Condition
Condition
Nursing students
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In pediatric nursing practices, the learning effect is measured based on the evaluation of the learner by using a realistic infant model that reproduces the movements of child.
Basic objectives2
Others
Basic objectives -Others
The target number of cases is 154
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)Achievement of pediatric nursing skills (2)Student satisfaction and confidence in learning (3)Evaluation of the exercise
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who have completed the required courses in the field of pediatric nursing, have confirmed their grades, and have agreed to participate in this study.
Key exclusion criteria
Those who are not feeling well on the day of the exercise.
Target sample size
154
Research contact person
Name of lead principal investigator
| 1st name | Kanako |
| Middle name | |
| Last name | YAMADA |
Organization
Gifu University
Division name
Department of Nursing, Faculty of Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu
TEL
0582933217
yamada.kanako.g8@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | YAMADA |
Organization
Gifu University
Division name
Department of Nursing, Faculty of Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu
TEL
0582933217
Homepage URL
yamada.kanako.g8@f.gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
1-1 Yanagido, Gifu City, Gifu
Address
1-1 Yanagido, Gifu City, Gifu
Tel
0582306059
rinri@t.gifu-u.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
| 2023 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 11 | Month | 16 | Day |
Last modified on
| 2024 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060267
