UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038286 |
|---|---|
| Receipt number | R000043642 |
| Scientific Title | Development of educational model for palpation skill using ultrasonography |
| Date of disclosure of the study information | 2019/10/15 |
| Last modified on | 2023/10/17 10:37:02 |
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Basic information
Public title
Investigation of skill acquirement on medical students using ultrasonography
Acronym
Effect of skill acquirement with ultrasonography
Scientific Title
Development of educational model for palpation skill using ultrasonography
Scientific Title:Acronym
Improvement of palpation skill with ultrasonography
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of ultrasonography on the skill training for palpation for medical students and fresh physical therapists.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Score for palpation skill (12 weeks after training)
Key secondary outcomes
Questionnaire about lecture
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) 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
| Maneuver |
Interventions/Control_1
Lecture using ultrasonography
90 min./session
first week, 3rd week, and 5th week
Interventions/Control_2
Usual lecture
90 min./session
first week, 3rd week, and 5th week
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Medical student in first or second grade, and freshman as a physical therapist.
2. Aged over 18 years old.
3. Subject who informed this trial and agreed for joining.
Key exclusion criteria
1. Subject with sensory disorder on fingers.
2. Past worker as medical profession an/or health care.
3. Subject who is regarded as not participant.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kitagawa |
Organization
Shinshu University
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621 Japan
TEL
0263-37-2413
tkitagawa@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kitagawa |
Organization
Shinshu University
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621 Japan
TEL
0263-37-2413
Homepage URL
tkitagawa@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Physical Therapy, School of Health Sciences, Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University
Address
3-1-1 Asahi, Matsumoto, Nagano, 390-8621 Japan
Tel
0263-37-2413
tkitagawa@shinshu-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
| 2019 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000043642&flwp_key=100592EVwAu
Publication of results
Partially published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view_cb.cgi?recptno=R000043642&flwp_key=100592EVwAu
Number of participants that the trial has enrolled
29
Results
Education using ultrasound imaging may be non inferior to education without it. Nevertheless, further studies are needed to demonstrate superiority.
Results date posted
| 2022 | Year | 04 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy university students
Participant flow
Thirty-eight people applied, and 29 were randomized after they were checked to see if they met the eligibility criteria.
Adverse events
Nothing in particular
Outcome measures
accuracy score, speed score, and combined total score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 10 | Month | 14 | Day |
Last modified on
| 2023 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043642
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/04/14 | 計画書.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/04/14 | 現在準備中.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/04/14 | 現在準備中.pdf |
