UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048618 |
|---|---|
| Receipt number | R000055396 |
| Scientific Title | Educational effects of the practicum participating simulated birthing women for midwifery students just prior to practice: changes in willingness for clinical practice. |
| Date of disclosure of the study information | 2022/08/07 |
| Last modified on | 2025/03/31 20:02:12 |
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Basic information
Public title
Verification of whether the simulation practicum on-campus for students becoming midwives change their willingness toward clinical practice.
Acronym
Changes in students' willingness to practice midwifery.
Scientific Title
Educational effects of the practicum participating simulated birthing women for midwifery students just prior to practice: changes in willingness for clinical practice.
Scientific Title:Acronym
Educational effects of the practicum participating simulated parturient women for midwifery students just prior to practice.
Region
| Japan |
Condition
Condition
Willingness of midwifery students preparing for assisted childbirth practice.
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether midwifery students' simulation practicum of childbirth assistance with the participation of simulated birthing women on campus as a preliminary stage of childbirth assistance practice reduces excessive anxiety and fear and improves their "willingness to practice," which is the positive and proactive attitude toward practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Midwifery students' willingness for practical training for assisted childbirth. Using the "Midwifery Students' Willingness to Practice Scale," a questionnaire will be used to measure and compare before and after the simulation practicum.
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
Uncontrolled
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
One on-campus childbirth assistance simulation practicum of 2 hours per session in which a simulated birthing woman performs the first and second stages of labor.
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
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
A midwifery student who is enrolled in the midwifery course of the Nursing Department of University A who is about to undergo assisted childbirth practice.
Key exclusion criteria
None
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Higashihara |
Organization
Saitama Prefectural University
Division name
Department of Nursing
Zip code
343-8540
Address
820 Sannomiya, Koshigaya-shi, Saitama, Japan.
TEL
048-973-4175
higashihara-akiko@spu.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Higashihara |
Organization
Saitama Prefectural University
Division name
Department of Nursing
Zip code
343-8540
Address
820 Sannomiya, Koshigaya-shi, Saitama, Japan.
TEL
048-973-4175
Homepage URL
higashihara-akiko@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Saitama Prefectural 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
Saitama Prefectural University Ethics Committee
Address
820 Sannomiya, Koshigaya-shi, Saitama, Japan.
Tel
048-973-4120
rinri@spu.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 | 08 | Month | 07 | 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
44
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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 07 | 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
| 2022 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055396
