UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057697 |
|---|---|
| Receipt number | R000065872 |
| Scientific Title | Evaluating the Educational Effectiveness of a Virtual Reality-Based Training Program for Initial Postpartum Hemorrhage Response in Basic Midwifery Education: The Impact of Learning Sequence on Educational Outcomes |
| Date of disclosure of the study information | 2025/04/24 |
| Last modified on | 2025/04/23 16:17:14 |
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Basic information
Public title
Evaluating the Educational Effectiveness of a Virtual Reality-Based Training Program for Initial Postpartum Hemorrhage Response in Basic Midwifery Education
Acronym
Evaluating the Educational Effectiveness of a Virtual Reality-Based Training Program for Initial Postpartum Hemorrhage Response in Basic Midwifery Education
Scientific Title
Evaluating the Educational Effectiveness of a Virtual Reality-Based Training Program for Initial Postpartum Hemorrhage Response in Basic Midwifery Education: The Impact of Learning Sequence on Educational Outcomes
Scientific Title:Acronym
Evaluating the Educational Effectiveness of a Virtual Reality-Based Training Program for Initial Postpartum Hemorrhage Response in Basic Midwifery Education: The Impact of Learning Sequence on Educational Outcomes
Region
| Japan |
Condition
Condition
Midwifery student
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In developing an educational program for students who want to become midwives to learn how to deal with abnormal postpartum hemorrhage, we will examine whether there is a difference in educational effectiveness depending on the learning sequence using lectures, mannequin models, and VR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective Structured Clinical Examination for Responding to Abnormal Postpartum Hemorrhage(Performed before and after intervention)
Key secondary outcomes
Course Interest Survey (Perform after intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
(1)Lecture (2)VR (3)Task training (About 4 hours.Participation is one time only)
Interventions/Control_2
(1)Lecture (2)Task training (3)VR (About 4 hours.Participation is one time only)
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
(1)Midwifery students in their final year of midwifery basic education.
(2)Those who have experienced at least one case of assisting in a delivery during midwifery practice.
Key exclusion criteria
(1)People who are not in good physical condition and those who are prone to motion sickness.
(2)People who have no vision at all, or people who cannot see even after adjusting the visibility of images on VR equipment.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mieko |
| Middle name | |
| Last name | Uchiyama |
Organization
Niigata University
Division name
Graduate School of Health Sciences
Zip code
951-8518
Address
746 Asahimachi-dori 2-ban-cho, Chuo-ku, Niigata City, Niigata Prefecture.
TEL
0252272263
uchiyama@clg.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | yumika |
| Middle name | |
| Last name | Tachikawa |
Organization
Niigata University
Division name
Department of Nursing, School of Health Sciences Faculty of Medicine.
Zip code
9518518
Address
746 Asahimachi-dori 2-ban-cho, Chuo-ku, Niigata City, Niigata Prefecture.
TEL
0252272364
Homepage URL
ytachi@clg.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Yumika Tachikawa
Funding Source
Organization
Niigata University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Niigata Seiryo University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Niigata University
Address
1-757, Asahimachi-dori, Chuo-ku, Niigata City ,Japan
Tel
025-227-2625
ethics@adm.niigata-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
| 2025 | Year | 04 | Month | 24 | 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
| 2025 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 04 | Month | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065872
