UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050516 |
|---|---|
| Receipt number | R000057532 |
| Scientific Title | Development of 3D learning materials for beginning ECG students through collaboration between design and nursing |
| Date of disclosure of the study information | 2023/03/11 |
| Last modified on | 2023/03/07 11:31:29 |
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Basic information
Public title
Development of 3D learning materials for beginning ECG students through collaboration between design and nursing
Acronym
Development of 3D learning materials for beginning ECG students
Scientific Title
Development of 3D learning materials for beginning ECG students through collaboration between design and nursing
Scientific Title:Acronym
Development of 3D learning materials for beginning ECG students
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to develop a theoretical framework for the development of 3D learning materials, and to produce and evaluate prototypes of the materials in order to develop learning materials that will assist beginning ECG students in their studies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in participants' test scores for basic knowledge required for ECG decoding after attending the workshop.
Key secondary outcomes
Change in participants' perception of their difficulty in learning ECG before and after attending the workshop."Likert-type multiple-choice questions"
Change in participants' opinions about the design of the course materials before and after attending the workshop "Likert-type multiple-choice questions"
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Other |
Interventions/Control_1
Conduct a 50-minute EKG workshop for 40 nursing students using the developed 3D model teaching materials.
Interventions/Control_2
Conduct a 50-minute EKG workshop for 40 nursing students using printed resource materials, followed by a 50-minute EKG workshop using the developed 3D model materials.
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
Nursing students who have applied for a research participation request.
Nursing students who have completed the EKG study of their curriculum.
Key exclusion criteria
Students with professional experience as nurses
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | WAKAKO |
| Middle name | |
| Last name | SADAHIRO |
Organization
Sapporo City University
Division name
School of Nursing
Zip code
0600011
Address
Kita11 Nishi13 Chuoku Sapporo City
TEL
011-726-2500
w.sadahiro@scu.ac.jp
Public contact
Name of contact person
| 1st name | WAKAKO |
| Middle name | |
| Last name | SADAHIRO |
Organization
Sapporo City University
Division name
School of Nursing
Zip code
0600011
Address
Kita11 Nishi13 Chuoku Sapporo City
TEL
011-726-2500
Homepage URL
w.sadahiro@scu.ac.jp
Sponsor or person
Institute
Sapporo City University
Institute
Department
Personal name
Funding Source
Organization
Sapporo City University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo City University Ethics Committee
Address
1,Geijyutu no Mori, Minami-ku, Sapporo City Japan
Tel
011-592-2346
rinri-sinsei@jimu.scu.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
AP品川（東京都）,札幌市立大学（北海道）
AP SHINAGAWA(TOKYO), Sapporo City University(Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 11 | 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
| 2022 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2024 | 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 | 03 | Month | 07 | Day |
Last modified on
| 2023 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057532
