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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000041643 |
Receipt No. | 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 | 2020/09/02 |
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 |
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Condition | ||
Condition | healthy adults | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
Institute | Aichi Children's Health and Medical Center |
Institute | |
Department |
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 |
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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 |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045169 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |