UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055639 |
|---|---|
| Receipt number | R000062080 |
| Scientific Title | Development and validation of new infusion flow control methods |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2025/09/26 11:56:22 |
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Basic information
Public title
Development and validation of new infusion flow control methods
Acronym
Development and validation of new infusion flow control methods
Scientific Title
Development and validation of new infusion flow control methods
Scientific Title:Acronym
Development and validation of new infusion flow control methods
Region
| Japan |
Condition
Condition
Healthy Adults(Nursing students)
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the advantages of the new method of adjusting infusion flow rate compared to the conventional method
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time for adjusting infusion flow rate and accuracy of flow rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional method of IV flow rate adjustment(adjusting IV flow rate while watching the clock)
Interventions/Control_2
New method of IV flow rate adjustment(adjusting IV flow rate while listening to the clock sound)
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
2nd-4th year nursing students at University A
Key exclusion criteria
Persons with severe visual or hearing impairment, persons with sensory sensitivity or sensory disturbance, and persons with a diagnosis of developmental disorder
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Nagashima |
Organization
Kanagawa University of Human Services
Division name
School of Nursing, Faculty of Health and Social Services
Zip code
238-8522
Address
1-10-1, Heisei-cho, Yokosuka-city, Kanagawa
TEL
+81-46-828-2638
nagashima-dnf@kuhs.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Nagashima |
Organization
Kanagawa University of Human Services
Division name
School of Nursing, Faculty of Health and Social Services
Zip code
238-8522
Address
1-10-1, Heisei-cho, Yokosuka-city, Kanagawa
TEL
+81-46-828-2638
Homepage URL
nagashima-dnf@kuhs.ac.jp
Sponsor or person
Institute
Kanagawa University of Human Services
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB in Kanagawa University of Human Services
Address
1-10-1, Heisei-cho, Yokosuka-city, Kanagawa
Tel
+81-46-828-2530
kenkyuurinri@kuhs.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
| 2024 | Year | 10 | Month | 01 | 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
14
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 08 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062080
