UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057206 |
|---|---|
| Receipt number | R000064895 |
| Scientific Title | A study on the effectiveness of peer assisted learning in suture practice |
| Date of disclosure of the study information | 2025/03/05 |
| Last modified on | 2025/03/04 19:38:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on the effectiveness of peer assisted learning in suture practice
Acronym
A study on the effectiveness of peer assisted learning in suture practice
Scientific Title
A study on the effectiveness of peer assisted learning in suture practice
Scientific Title:Acronym
A study on the effectiveness of peer assisted learning in suture practice
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Skin suturing is considered to be one of the skills that medical students should master, but there is no standardized educational method, and the degree of mastery varies. In addition, peer assisted learning is a learning method in which learners cooperate with each other and are assisted by their peers rather than instructors. In the field of medical education, there are reports that peer assisted learning has the same educational effect as instructor-led instruction in basic surgical procedures and that it has deepened motivation and self-motivation for surgical procedures. However, as far as we could find, there are no objective reports of the educational effect of epidermal suturing by peer assisted learning conducted by plastic surgeons. In addition, although teaching students is one of the duties of physicians affiliated with university hospitals such as ours, they are sometimes burdened with time constraints, and instructors are chronically short-staffed.
This study was designed to investigate the effects of peer-assisted learning on awareness, behavior change, and skill acquisition in suture practice, and to verify its effectiveness.
The purpose of this study is to objectively evaluate the effectiveness of peer assisted learning in suturing practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of suturing skills of 6th graders in the intervention and non-intervention groups at the beginning and end of the training
Key secondary outcomes
Comparison of Attitude and Behavior Change in 6th Grade Students in Intervention and Non-Intervention Groups
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The subjects will be divided into two groups: a peer group that will receive suture instruction for 60 minutes x 2 times to 5th-year medical students rotating through the Department of Plastic Surgery during their basic clinical training, and a control group that will not receive any suture instruction. The peer group will participate in the suture practice as a supervisor during the basic clinical practice in the fifth year. The peer group will participate as instructors in the suture practice in the basic clinical training of the fifth-year students.
The peer group will participate as instructors in the suture practice in the basic clinical practice in the 5th year.
The research subjects in both groups will suture a skin model at the beginning of their training and undergo an evaluation of their skills in epidermal suturing. They will also complete a questionnaire regarding their confidence and self-efficacy in surgical skills.
For the purpose of skill evaluation, a video of the suture hand only will be taken during suturing. The video data will not be personally identifiable. The video recording equipment will be prepared by the researcher, and the video recording will be conducted by the researcher.
Photographs of the sutured skin model will be taken for the purpose of technological evaluation. The equipment will be prepared by the investigator and the photographs will be taken by the investigator.
The control group will receive only standard education and will not be given any instructional opportunities.
The control group will receive only standardized education and will not be given any instructional opportunities. They will also complete the same questionnaire. The questionnaire will be completed online using Microsoft forms.
The 5th year students will only have their regular clinical practice. It is normal for sixth-year students to participate in the clinical practice of fifth-year students, and fifth-year students are not considered as research subjects.
Interventions/Control_2
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
(1)Students who will undergo elective clinical training at the Department of Plastic and Reconstructive Surgery, Okayama University Hospital in academic year 2025 and who are 6th year medical students at Okayama University School of Medicine and who are capable of obtaining written consent for participation in this study of their own free will after receiving sufficient explanation and understanding of the study.
(2) Students who are 18 years of age or older at the time of obtaining consent.
Key exclusion criteria
(1) Students who have difficulty performing suture practice due to trauma, etc.
(2) Other students whom the principal investigator or subinvestigator determines to be inappropriate as research subjects
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Takanari |
Organization
Okayama University Hospital
Division name
plastic surgery
Zip code
700-8558
Address
2-5-1,Shikata-cho,Kita-ku,Okayama-city,Okayama
TEL
0862357214
k-takanari@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Hayashi |
Organization
Okayama University Hospital
Division name
plastic surgery
Zip code
700-8558
Address
2-5-1,Shikata-cho,Kita-ku,Okayama-city,Okayama
TEL
0862357214
Homepage URL
me20067@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Hospital
Address
2-5-1,Shikata-cho,Kita-ku,Okayama-city,Okayama
Tel
0862357214
me20067@s.okayama-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
| 2025 | Year | 03 | Month | 05 | 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
| 2025 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 03 | Month | 04 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064895
