UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050798
Receipt number R000057888
Scientific Title An Open-Label, Randomized Controlled Trial to Test the Educational Effectiveness of a Smartphone App for Cardiopulmonary Resuscitation Training Using Augmented Reality (AR) Technology
Date of disclosure of the study information 2023/05/01
Last modified on 2025/04/11 09:01:58

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Basic information

Public title

Verification of the educational effectiveness of a Smartphone Application for Cardiopulmonary Resuscitation Training Using Augmented Reality Technology

Acronym

CPR-AR Trial

Scientific Title

An Open-Label, Randomized Controlled Trial to Test the Educational Effectiveness of a Smartphone App for Cardiopulmonary Resuscitation Training Using Augmented Reality (AR) Technology

Scientific Title:Acronym

CPR-AR Trial

Region

Japan


Condition

Condition

Out-of-Hospital Cardiac Arrest

Classification by specialty

Emergency medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Bystander use of CPR and AEDs is critical to improving the survival rate of out-of-hospital cardiac arrest victims. Traditionally, cardiopulmonary resuscitation (CPR) training has been conducted in a classroom setting where participants learn through instructor demonstrations, video images, and practice on manikins. However, with the spread of COVID-19, there is a need for non-face-to-face, non-contact training. Therefore, we developed a new method of CPR training using augmented reality (AR) technology, called "CPR AR". The purpose of this study is to verify whether or not the use of this technology improves the knowledge and skills of citizens regarding CPR.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Quality of chest compressions (depth, tempo, return of compressions, and position of compressions) performed by the subject immediately after the study

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

5-minute training with the "Cardiopulmonary Resuscitation AR" smart phone app

Interventions/Control_2

5-minute video study of the "Series of CPR" on the Fire and Disaster Management Agency's First Aid Web site

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

25 years-old >

Gender

Male and Female

Key inclusion criteria

Students who have already earned credits or are currently enrolled in "Primary Life Saving Procedures," a health and welfare liberal arts course at Niigata University of Health and Welfare, and who have responded to the open application via e-mail.

Key exclusion criteria

Persons who have taken a CPR course using mannequins within the last 6 months.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kentaro
Middle name
Last name Omatsu

Organization

Niigata University of Health and Welfare

Division name

Department of Emergency Medical Sciences

Zip code

950-3198

Address

1398, Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan

TEL

0252574641

Email

omatsu@nuhw.ac.jp


Public contact

Name of contact person

1st name Kentaro
Middle name
Last name Omatsu

Organization

Niigata University of Health and Welfare

Division name

Department of Emergency Medical Sciences

Zip code

950-3198

Address

1398, Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan

TEL

0252574641

Homepage URL


Email

omatsu@nuhw.ac.jp


Sponsor or person

Institute

Niigata University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Review Committee, Niigata University of Health and Welfare

Address

1398, Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan

Tel

025-257-4455

Email

rinri@nuhw.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

2023 Year 05 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

2023 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2023 Year 05 Month 08 Day

Last follow-up date

2026 Year 03 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

2023 Year 04 Month 10 Day

Last modified on

2025 Year 04 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057888