UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051575 |
|---|---|
| Receipt number | R000058844 |
| Scientific Title | Effects of ampule-cutting index finger fixation on ampule cut surface, presence of cut, and upper limb movement |
| Date of disclosure of the study information | 2023/07/12 |
| Last modified on | 2024/01/09 18:18:49 |
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Basic information
Public title
Effects of ampule-cutting index finger fixation on ampule cut surface, presence of cut, and upper limb movement
Acronym
Effects of index finger fixation on ampule cutting
Scientific Title
Effects of ampule-cutting index finger fixation on ampule cut surface, presence of cut, and upper limb movement
Scientific Title:Acronym
Effects of index finger fixation on ampule cutting
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify effects of ampule-cutting index finger fixation on ampule cut surface, presence of cut, and upper limb movement.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cutting surface of ampoule
Key secondary outcomes
Items related to the background of the participants; age, gender
Presence or absence of cut wounds
Upper limb movement
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Fixation of index finger in ampule cutting
Interventions/Control_2
No index finger fixation when cutting ampoule
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
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Already learned ampoule cutting in school, but have no experience with ampoule cutting outside of class.
No limitation of upper limb motion
No skin problems on hands and fingers
No allergies to the following items used for hand sanitization;wound dressing,gloves
Right-hander
Key exclusion criteria
Those who do not meet the selection criteria
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Healthcare University
Division name
Division of Nursing, Higashigaoka Faculty of Nursing
Zip code
152-8558
Address
2-5-1,Higashigaoka, Meguro, Tokyo
TEL
03-5779-5031
to-takahashi@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Healthcare University
Division name
Division of Nursing, Higashigaoka Faculty of Nursing
Zip code
152-8558
Address
2-5-1,Higashigaoka, Meguro, Tokyo
TEL
03-5779-5031
Homepage URL
to-takahashi@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Healthcare University
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
the Ethical Review Board for Human-related Research, Tokyo Healthcare University
Address
4-1-17,Higashigotanda, Shinagawa, Tokyo
Tel
03-5721-7655
rinri@thcu.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
東京医療保健大学 東が丘看護学部（東京都）
Tokyo Healthcare University Higashigaoka Faculty of Nursing（Tokyo）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 12 | 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
34
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
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 10 | Month | 27 | Day |
Date trial data considered complete
| 2023 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058844
