UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041643 |
|---|---|
| Receipt number | R000045169 |
| Scientific Title | Comparison of learners' performance and subjective workload in rapid cycle deliberate practice and traditional simulation in pediatric anesthesia: a pilot study |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2022/03/05 09:47:58 |
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Basic information
Public title
Comparison of learners' performance in rapid cycle deliberate practice and traditional simulation in pediatric anesthesia: a pilot study
Acronym
Comparison of learners' performance in rapid cycle deliberate practice and traditional simulation in pediatric anesthesia: a pilot study
Scientific Title
Comparison of learners' performance and subjective workload in rapid cycle deliberate practice and traditional simulation in pediatric anesthesia: a pilot study
Scientific Title:Acronym
Comparison of learners' performance and subjective workload in rapid cycle deliberate practice and traditional simulation in pediatric anesthesia: a pilot study
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe and compare the learners' technical s skills scores and non-technical skills scores in rapid cycle deliberate practice (RCDP) and traditional style simulation
Basic objectives2
Others
Basic objectives -Others
To describe and compare the learners' subjective workload in rapid cycle deliberate practice (RCDP) and traditional style simulation
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Technical skills assessment score developed by the research team
Anesthesia non-technical skills score
NASA LTX
All assessment simulation sessions will be video recorded which will be reviewed by two independent raters within 5 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Rapid cycle deliberate practice will be used in a training sessions by a facilitator. Participants will complete 4 pediatric anesthesia simulation scenarios(1 hour for each session) created with a consensus among independent 3 outside board certified anesthesiologists. Pre and post-assessment simulation sessions will be conducted for each scenario in each participant. All of the assessment simulation sessions will be video recorded and will be assessed by independent 2 raters later.
Interventions/Control_2
Traditional style simulation practice will be used in a training sessions by a facilitator. Participants will complete 4 pediatric anesthesia simulation scenarios(1 hour for each session) created with a consensus among independent 3 outside board certified anesthesiologists. Pre and post-assessment simulation sessions will be conducted for each scenario in each participant. All of the assessment simulation sessions will be video recorded and will be assessed by independent 2 raters later.
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
Pediatric anesthesia fellows and junior anesthesiologists who are younger than post-graduate-year 10 at Aichi Children's Health and Medical Center
Key exclusion criteria
Subjects who denied the study participation with any reasons
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | TAIKI |
| Middle name | |
| Last name | KOJIMA |
Organization
Aichi Children's Health and Medical Center
Division name
Anesthesiology
Zip code
474-8710
Address
7-426, Morioka-cho, Obu city, Aichi, Japan
TEL
0562-43-0500
daiki_kojima@sk00106.achmc.pref.aichi.jp
Public contact
Name of contact person
| 1st name | TAIKI |
| Middle name | |
| Last name | KOJIMA |
Organization
Aichi Children's Health and Medical Center
Division name
Anesthesiology
Zip code
474-8710
Address
7-426, Morioka-cho, Obu city, Aichi, Japan
TEL
0562-43-0500
Homepage URL
daiki_kojima@sk00106.achmc.pref.aichi.jp
Sponsor or person
Institute
Aichi Children's Health and Medical Center
Institute
Department
Personal name
Funding Source
Organization
Aichi Children's Health and Medical Center
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
Aichi Children's Health and Medical Center
Address
7-426, Morioka-cho, Obu city, Aichi, Japan
Tel
0562-43-0500
kenzi_okada@sk00106.achmc.pref.aichi.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
| 2020 | 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
| Delay expected |
Results Delay Reason
The participant's inclusion has not been initiated due to COVID surge in Japan
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
| 2020 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 02 | Day |
Last modified on
| 2022 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045169
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
