UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000053487
Receipt number R000061050
Scientific Title Evaluating the Efficacy of First-Person Perspective Simulation Video for Non-Technical Skill Training in Airway Management during Clinical Clerkship.
Date of disclosure of the study information 2024/01/31
Last modified on 2024/01/31 02:06:03

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Basic information

Public title

Evaluating the Efficacy of First-Person Perspective Simulation Video for Non-Technical Skill Training in Airway Management during Clinical Clerkship.

Acronym

Evaluating the Efficacy of First-Person Perspective Simulation Video for Non-Technical Skill Training in Airway Management during Clinical Clerkship.

Scientific Title

Evaluating the Efficacy of First-Person Perspective Simulation Video for Non-Technical Skill Training in Airway Management during Clinical Clerkship.

Scientific Title:Acronym

Evaluating the Efficacy of First-Person Perspective Simulation Video for Non-Technical Skill Training in Airway Management during Clinical Clerkship.

Region

Japan


Condition

Condition

None

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Develop educational First-Person Perspective Simulation Video during anesthetic induction by an expert anesthesiologist, and test the hypothesis that displaying gaze points is effective in helping medical students acquire non-technical skills for airway management.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Kirkpatrick Model
Reaction: Surveys immediately after the simulation practice (Quantitative Assessment: Likert Scale, Qualitative Assessment: Free-text responses)
Learning: Scores from written examinations, scores from evaluator's checklist, evaluator's Global Rating Scale
Behavior: Surveys at the completion of the anesthesiology clinical internship period (Quantitative Assessment: Likert Scale, Qualitative Assessment: Free-text responses)




Key secondary outcomes

Cognitive Load Scale, Number of Fixations and Dwell Time on Areas of Interest


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

The presence of gaze point display in educational First-Person Perspective Simulation Video during anesthesia induction by an expert anesthesiologist.

Interventions/Control_2

The absence of gaze point display in educational First-Person Perspective Simulation Video during anesthesia induction by an expert anesthesiologist.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Medical students in their clinical clerkship period who applied for volunteers to participate in the research (4th-year undergraduates (M4) and 5th-year undergraduates (M5)).

Key exclusion criteria

Individuals with a history of eye surgery.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Unuma

Organization

Akita University Graduate School of Medicine

Division name

Department of Anesthesia and Intensive Care Medicine

Zip code

010-8543

Address

1-1-1, Hondo, Akita-city, Akita

TEL

018-884-6175

Email

unuma18@med.akita-u.ac.jp


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Unuma

Organization

Akita University Graduate School of Medicine

Division name

Department of Anesthesia and Intensive Care Medicine

Zip code

018-884-6175

Address

1-1-1, Hondo, Akita-city, Akita

TEL

018-884-6175

Homepage URL


Email

unuma18@med.akita-u.ac.jp


Sponsor or person

Institute

Akita University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Akita University School of Medicine Ethics Committee

Address

1-1-1, Hondo, Akita-city, Akita

Tel

018-884-6216

Email

soken@hos.akita-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

2024 Year 01 Month 31 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

Open public recruiting

Date of protocol fixation

2024 Year 01 Month 31 Day

Date of IRB

2024 Year 01 Month 23 Day

Anticipated trial start date

2024 Year 01 Month 31 Day

Last follow-up date

2024 Year 10 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

2024 Year 01 Month 31 Day

Last modified on

2024 Year 01 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061050