UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063442 |
|---|---|
| Receipt number | R000071073 |
| Scientific Title | Basic Principles and Instructional Methods for Grasping in Microsurgical Technique: An Exploratory Study |
| Date of disclosure of the study information | 2026/11/15 |
| Last modified on | 2026/11/15 21:49:46 |
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Basic information
Public title
Basic Principles and Instructional Methods for Grasping in Microsurgical Technique: An Exploratory Study
Acronym
Study of Grasping Tasks in Microsurgical Technique
Scientific Title
Basic Principles and Instructional Methods for Grasping in Microsurgical Technique: An Exploratory Study
Scientific Title:Acronym
Study of Grasping Tasks in Microsurgical Technique
Region
| Japan |
Condition
Condition
Not applicable (educational study involving healthy adult volunteers)
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine whether research participants can appropriately apply basic grasping principles for linear objects under a microscopic environment. In addition, this study will evaluate the effect of a brief conceptual explanation of these principles on performance in a grasping task, and will explore appropriate initial instructional methods for microsurgical education. The findings of this study are expected to provide foundational data for designing educational approaches that promote understanding of basic motor principles before teaching technical procedures.
Basic objectives2
Others
Basic objectives -Others
To exploratorily evaluate grasping task performance in microsurgical education and the educational effect of a brief conceptual explanation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Time from task initiation to the first successful grasp in the second microscopic grasping task performed under the immediate-intervention or wait-list control condition. The time will be measured in seconds from the start of the task until the participant first successfully grasps and lifts the linear object with forceps, and will be compared between the immediate-intervention group and the wait-list control group.
Key secondary outcomes
Key secondary outcomes include the success rate, number of regrasp attempts, number of misses, and number of slips in the second microscopic grasping task performed under the immediate-intervention or wait-list control condition. Changes in task completion time, success rate, number of regrasp attempts, number of misses, and number of slips from the first microscopic grasping task to the second microscopic grasping task will also be evaluated. Success is defined as grasping the linear object with forceps and moving it to the designated position within the predefined time limit. Regrasp attempts are defined as repeated grasping attempts required to complete the task. Misses are defined as grasping attempts in which the object is not successfully grasped. Slips are defined as events in which the object slips or drops after being grasped.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
After completing the grasping task under macroscopic conditions (Step 1) and the grasping task under microscopic conditions (Step 2), participants receive a brief conceptual explanation (approximately 2-3 minutes) of the basic motor principles related to grasping direction for linear objects. The explanation focuses on recognizing these principles through familiar everyday grasping movements, without providing specific instructions on instrument manipulation or hand positioning. Participants then perform the microscopic grasping task (Step 3) under the same conditions as Step 2. The intervention is provided only once during a single study session.
Interventions/Control_2
After completing the grasping task under macroscopic conditions (Step 1) and the grasping task under microscopic conditions (Step 2), participants perform the microscopic grasping task (Step 3) under the same conditions as Step 2, without receiving the conceptual explanation beforehand. After completing Step 3, participants receive the same conceptual explanation (approximately 2-3 minutes) as the immediate intervention group. The intervention is provided only once during a single study session.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Adults aged 20 years or older.
2. Medical students, junior residents, or neurosurgeons.
3. Individuals who fully understand the study procedures and voluntarily provide written informed consent.
Key exclusion criteria
1. Individuals who are considered unable to adequately understand the study or make an informed decision regarding participation.
2. Individuals who do not provide written informed consent.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ayumu |
| Middle name | |
| Last name | Yamaoka |
Organization
Sapporo Meidcal University
Division name
Department of Neurosurgery
Zip code
060-8543
Address
South 1 West 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
yamaoka@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Ayumu |
| Middle name | |
| Last name | Yamaoka |
Organization
Sapporo Meidcal University
Division name
Department of Neurosurgery
Zip code
060-8543
Address
South 1 West 16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
yamaoka@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Ayumu Yamaoka
Funding Source
Organization
Sapporo Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University Ethics Committee
Address
South 1 West 16, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
011-611-2111
riri@sapmed.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
| 2026 | Year | 11 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 10 | Month | 28 | Day |
Last modified on
| 2026 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071073
