UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042058
Receipt number R000047932
Scientific Title Verification of training effect using breath sound auscultation simulator for paramedics
Date of disclosure of the study information 2020/10/08
Last modified on 2023/10/12 08:20:07

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Basic information

Public title

Verification of training effect using breath sound auscultation simulator for paramedics

Acronym

Verification of training effect using breath sound auscultation simulator for paramedics

Scientific Title

Verification of training effect using breath sound auscultation simulator for paramedics

Scientific Title:Acronym

Verification of training effect using breath sound auscultation simulator for paramedics

Region

Japan


Condition

Condition

none

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Understand the current state of auscultation skills for paramedics and examine the effectiveness of continuing education.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

In each training, we will investigate the breath sound auscultation skill using a simulator before the training starts and at the end of the training. The evaluation items are normal breath sounds, diminished unilateral breath sounds as abnormal breath sounds, wheezes, rhonchi, fine crackles, coarse crackles, and pleural friction rub. Ask the research subjects to answer in a descriptive manner about the nature and location of breath sounds.

Key secondary outcomes

A and B groups start intervention all at once.
After that, Group A will conduct additional training about every 3 months, and Group B will conduct additional training only about 6 months later. Investigate the progress of the training effect by measuring the effect before and after the training.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

The subjects of the study are divided into two groups, A group (intervention group) and B group (subject group). As for how to divide the groups, each person's respiratory sound auscultation skill is measured by the ability test conducted before and after the training, and based on that, the A group (intervention group) and the B group (target group) have similar results. Allocate to two groups so that they are composed of. The specific method is to arrange them in descending order of performance, and assign them alternately to group A (intervention group), group B (target group), group A (intervention group), and group B (target group) from the top. .. Group A (intervention group) will receive additional training and surveys only after 3 and 6 months. In the additional training, after investigating the breath sound auscultation skill using a simulator before the training, a video recording of the lecture in the first training will be viewed and a practical exercise using the simulator will be conducted. After the training, we will conduct a survey of breath sound auscultation skills using a simulator.

Interventions/Control_2

The subjects of the study are divided into two groups, A group (intervention group) and B group (subject group). As for how to divide the groups, each person's respiratory sound auscultation skill is measured by the ability test conducted before and after the training, and based on that, the A group (intervention group) and the B group (target group) have similar results. Allocate to two groups so that they are composed of. The specific method is to arrange them in descending order of performance, and assign them alternately to group A (intervention group), group B (target group), group A (intervention group), and group B (target group) from the top. Group B (target group) will only undergo additional training and surveys after 6 months. In the additional training, after investigating the breath sound auscultation skill using a simulator before the training, a video recording of the lecture in the first training will be viewed and a practical exercise using the simulator will be conducted. After the training, we will conduct a survey of breath sound auscultation skills using a simulator.

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

Those who have a paramedic license

Key exclusion criteria

Those who do not have a paramedic license

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yamauchi
Middle name
Last name Toyoaki

Organization

The Open University of Japan

Division name

Division of Human Life and Health Sciences Graduate School of Arts and Sciences

Zip code

261- 8586

Address

2-11 Wakaba, Mihama-ku, Chiba Japan

TEL

043-298-4149

Email

t-yamauchi@ouj.ac.jp


Public contact

Name of contact person

1st name Hiraiwa
Middle name
Last name Ryunosuke

Organization

The Open University of Japan

Division name

Division of Human Life and Health Sciences Graduate School of Arts and Sciences

Zip code

261- 8586

Address

2-11 Wakaba, Mihama-ku, Chiba Japan

TEL

070-3618-5000

Homepage URL


Email

ryu.medic99@gmail.com


Sponsor or person

Institute

The Open University of Japan
Division of Human Life and Health Sciences
Graduate School of Arts and Sciences

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


IRB Contact (For public release)

Organization

The Open University of Japan

Address

2-11 Wakaba, Mihama-ku, Chiba Japan

Tel

043-276-5111

Email

rinrishinsa@ouj.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

放送大学(千葉県)


Other administrative information

Date of disclosure of the study information

2020 Year 10 Month 08 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

No longer recruiting

Date of protocol fixation

2021 Year 09 Month 25 Day

Date of IRB

2020 Year 09 Month 28 Day

Anticipated trial start date

2020 Year 10 Month 14 Day

Last follow-up date

2022 Year 10 Month 14 Day

Date of closure to data entry

2024 Year 12 Month 16 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 10 Month 08 Day

Last modified on

2023 Year 10 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047932


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name