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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

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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
Email 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
Email 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
Email 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
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
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
2020 Year 09 Month 02 Day


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


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