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
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
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
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
