UMIN-CTR Clinical Trial

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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