UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052348 |
|---|---|
| Receipt number | R000059550 |
| Scientific Title | Development of a virtual reality app for neonatal resuscitation training and evaluation of the educational effectiveness |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2025/04/06 21:06:17 |
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Basic information
Public title
Development of a virtual reality app for neonatal resuscitation training and evaluation of the educational effectiveness
Acronym
VR app for neonatal resuscitation training
Scientific Title
Development of a virtual reality app for neonatal resuscitation training and evaluation of the educational effectiveness
Scientific Title:Acronym
VR app for neonatal resuscitation training
Region
| Japan |
Condition
Condition
Neonatal healthcare workers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a VR app for neonatal resuscitation training and examine its educational effectiveness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in total scores of the neonatal resuscitation performance scale (NCPR-PASS) immediately before and after training with the VR app or mannequins
Key secondary outcomes
Changes in the following variables immediately before and after training with the VR app or mannequins
-- knowledge test scores
-- NCPR-PASS scores by domain
-- NCPR performance as rated by global rating
-- self-efficacy as assessed by questionnaire
Occurrence of adverse events (e.g., VR sickness)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Receive scenario training on neonatal resuscitation using a VR app in addition to manual skills training with mannequins
Interventions/Control_2
Receive scenario training using mannequins in addition to manual skills training using mannequins
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
Male and Female
Key inclusion criteria
All of the following must be met at the time consent is obtained:
-- pediatric residents, neonatologists (within 3 years of neonatal care), or "nurses or midwives with less than 10 years of experiences
-- not certified as NCPR instructors
Key exclusion criteria
Those who meet any of the following:
-- Those with a history of severe headache or dizziness
-- Those who are judged by the principal investigator to be inappropriate as research subjects
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shoichiro |
| Middle name | |
| Last name | AMARI |
Organization
Graduate School, The University of Tokyo
Division name
Department of Clinical Information Engineering, School of Public Health, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3812-2111
cie-office@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shoichiro |
| Middle name | |
| Last name | AMARI |
Organization
Graduate School, The University of Tokyo
Division name
Department of Clinical Information Engineering, School of Public Health, Graduate School of Medicine
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3812-2111
Homepage URL
cie-office@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Shoichiro AMARI
Funding Source
Organization
The University of Tokyo
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
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 01 | 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
Suspended
Date of protocol fixation
| 2023 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2023 | Year | 09 | Month | 29 | Day |
Last modified on
| 2025 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059550
