UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063427 |
|---|---|
| Receipt number | R000072597 |
| Scientific Title | Creating and Testing the Feasibility of a Nursing Simulation Learning Scenario for the first Stage of Labor |
| Date of disclosure of the study information | 2026/10/27 |
| Last modified on | 2026/10/27 14:55:22 |
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Basic information
Public title
Creating and Testing the Feasibility of a Nursing Simulation Learning Scenario for the first Stage of Labor
Acronym
Creating and Testing the Feasibility of a Nursing Simulation Learning Scenario for the first Stage of Labor
Scientific Title
Creating and Testing the Feasibility of a Nursing Simulation Learning Scenario for the first Stage of Labor
Scientific Title:Acronym
Creating and Testing the Feasibility of a Nursing Simulation Learning Scenario for the first Stage of Labor
Region
| Japan |
Condition
Condition
Nursing simulation learning scenario for the first stage of labor
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to create a nursing simulation learning scenario for the first stage of labor in maternal nursing practice and to look into whether it can actually be carried out.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to assess changes in students' confidence in nursing during the first stage of labor.
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Confidence in nursing during the first stage of labor
Key secondary outcomes
General self-efficacy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Take a labor stage 1 nursing simulation course
Interventions/Control_2
Get hand-s on experience with labor care during clinical practice
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
Female
Key inclusion criteria
Out of 48 third-year nursing students taking the maternal nursing practice course, those who agreed to participate in the study
Key exclusion criteria
Someone who does not give consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Misato |
Organization
Kyoritsu women's University
Division name
Faculty of Nursing
Zip code
1010051
Address
3-27 kanda Jimbocho, Chiyoda-ku, Tokyo 101-0051, JAPAN
TEL
0332375667
kmisato@kyoritsu-wu.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Misato |
Organization
Kyoritsu Women's University
Division name
Faculty of Nursing
Zip code
1010051
Address
3-27 kanda Jimbocho, Chiyoda-ku, Tokyo 101-0051, JAPAN
TEL
0332375667
Homepage URL
kmisato@kyoritsu-wu.ac.jp
Sponsor or person
Institute
Kyoritsu Women's University
Institute
Department
Personal name
Kumiko Misato
Funding Source
Organization
Japan Nursing society for simulation and Nursing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoritsu Women's University and Kyoritsu Women's Junior College Research Ethics Review Committee
Address
3-27 kanda Jimbocho, Chiyoda-ku, Tokyo 101-0051, JAPAN
Tel
0332375667
kmisato@kyoritsu-wu.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
| 2026 | Year | 10 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 27 | Day |
Last modified on
| 2026 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072597
