UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049252 |
|---|---|
| Receipt number | R000056094 |
| Scientific Title | Evaluation of the effectiveness of VR teaching materials in retraining pharmacists after in situ simulation of emergency response-Multicenter randomized controlled trial. |
| Date of disclosure of the study information | 2022/10/19 |
| Last modified on | 2024/04/19 09:38:52 |
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Basic information
Public title
Evaluation of the effectiveness of VR teaching materials in retraining pharmacists after in situ simulation of emergency response-Multicenter randomized controlled trial.
Acronym
Evaluation of the effectiveness of VR teaching materials in retraining pharmacists after in situ simulation of emergency response.
Scientific Title
Evaluation of the effectiveness of VR teaching materials in retraining pharmacists after in situ simulation of emergency response-Multicenter randomized controlled trial.
Scientific Title:Acronym
Evaluation of the effectiveness of VR teaching materials in retraining pharmacists after in situ simulation of emergency response.
Region
| Japan |
Condition
Condition
Hospital pharmacists trained in in situ simulation of rapid response
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the non-inferiority of self-directed learning by Virtual Reality compared to face-to-face learning as a retraining method for in situ simulation of rapid response for hospital pharmacists.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BLS self-efficacy scores one year after in situ simulation training
Key secondary outcomes
(1) Amount of change in BLS self-efficacy scores one year after in situ simulation training
(2) Pass rate for BLS skills
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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
The VR group will be self-study with VR videos and resuscitation training kits; each study will last approximately 10 minutes and will be conducted once every three months.
Interventions/Control_2
The control group will be taught face-to-face by a researcher who is a certified ACLS instructor; each learning session will last approximately 10 minutes and will be conducted once every three months.
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
| 24 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hospital pharmacists trained in in situ simulation of rapid response
Key exclusion criteria
Exclude participants who plan to retire within one year.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Kazue |
| Middle name | |
| Last name | Nakajima |
Organization
Osaka University Hospital
Division name
Department of Clinical Quality Management
Zip code
565-0871
Address
2-15 Yamadaoka, Suita City, Osaka, Japan
TEL
0668795111
kazuen@hp-cqm.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | takuya |
| Middle name | |
| Last name | shintani |
Organization
Osaka University Hospital
Division name
Department of Clinical Quality Management
Zip code
565-0871
Address
2-15 Yamadaoka, Suita City, Osaka, Japan
TEL
0668795111
Homepage URL
shintani@hosp.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Research Review Committee
Address
2-2 Yamadaoka, Suita City, Osaka, Japan
Tel
0662108296
rinri@hp-crc.med.osaka-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
| 2022 | Year | 10 | Month | 19 | 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
hospital pharmacist
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 12 | 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 | 10 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056094
