UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049732 |
|---|---|
| Receipt number | R000056617 |
| Scientific Title | Development and validation of an educational program on epidural anesthesia delivery in basic midwifery education |
| Date of disclosure of the study information | 2022/12/10 |
| Last modified on | 2025/06/16 23:57:05 |
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Basic information
Public title
Development and validation of an educational program on epidural anesthesia delivery in basic midwifery education
Acronym
Development and validation of an educational program on epidural anesthesia delivery in basic midwifery education
Scientific Title
Development and validation of an educational program on epidural anesthesia delivery in basic midwifery education
Scientific Title:Acronym
Development and validation of an educational program on epidural anesthesia delivery in basic midwifery education
Region
| Japan |
Condition
Condition
midwifery student
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A midwife education program on epidural anesthesia delivery will be developed and a trial of the program will be conducted, after which the program will be refined again and the implementation of the program will be verified again.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knowledge immediately after program implementation, problems, issues and improvements in the educational program
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
single-arm study
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Students enrolled in midwifery training programs after attending lectures on low-risk labor and delivery
Key exclusion criteria
Students enrolled in midwifery training programs prior to attending lectures on low-risk labor and delivery
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kie |
| Middle name | |
| Last name | Hoshi |
Organization
University of the Human Environment Graduate School
Division name
Postdoctoral Program of Nursing Studies
Zip code
4740035
Address
3-220 Ebata-cho, Obu-shi, Aichi
TEL
0562430701
k-hoshi@uhe.ac.jp
Public contact
Name of contact person
| 1st name | Kie |
| Middle name | |
| Last name | Hoshi |
Organization
University of Human Environment
Division name
School of Nursing
Zip code
4740035
Address
3-220 Ebata-cho, Obu-shi, Aichi
TEL
0562430701
Homepage URL
k-hoshi@uhe.ac.jp
Sponsor or person
Institute
University of Human Environment
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Research Ethics Review Committee, University of Human Environments
Address
3-220 Ebata-cho, Obu-shi, Aichi
Tel
0562430701
k-hoshi@uhe.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
| 2022 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
https://researchmap.jp/2214
Publication of results
Unpublished
Result
URL related to results and publications
https://researchmap.jp/2214
Number of participants that the trial has enrolled
20
Results
Test scores significantly improved after the program. The epidural birth education program, which included selected midwifery care videos, was evaluated. Twelve categories related to interest and learning, and five categories for program evaluation were extracted. Key themes included the need for epidural education in midwifery training and realistic understanding through models and videos.
Results date posted
| 2025 | Year | 06 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Fifteen participants from five midwifery training programs participated in this study. Thirteen (86.7%) were in graduate school and two (13.3%) were in undergraduate school, all in their final year of midwifery training. It was validated for five students in a midwifery training program.
Participant flow
This study was a single-group, non-interventional observational study. The inclusion criterion was enrollment in a midwifery education program and completion of a lecture on low-risk childbirth. All eligible students who provided informed consent were included in the study unless they met the exclusion criteria.
Adverse events
Not Applicable
Outcome measures
Knowledge immediately after program implementation, problems, issues and improvements in the educational program
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 12 | Month | 08 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056617
