UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049441 |
|---|---|
| Receipt number | R000056291 |
| Scientific Title | Effect of local heating for venous dilation of peripheral venipuncture |
| Date of disclosure of the study information | 2022/11/07 |
| Last modified on | 2024/10/21 09:43:42 |
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Basic information
Public title
Effect of local heating for venous dilation of peripheral venipuncture
Acronym
Effect of local heating for venous dilation of peripheral venipuncture
Scientific Title
Effect of local heating for venous dilation of peripheral venipuncture
Scientific Title:Acronym
Effect of local heating for venous dilation of peripheral venipuncture
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of different ranges of local heating on venous dilation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
vein diameter
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Local heating of forearm (10 min)
Interventions/Control_2
Local heating of puncture site (10 min)
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
No disease, non-smoker
Key exclusion criteria
Skin disease or skin damage on the left upper extremity
History of cold burns
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Miharu |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyushu University
Division name
Department of Health Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL
092-642-4891
matsumoso.miharu.953@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Miharu |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyushu University
Division name
Department of Health Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL
092-642-4891
Homepage URL
matsumoso.miharu.953@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Department of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
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
Kyushu University Ethical Review Committe
Address
3-1-1 Maidashi, Higashi-Ku, Fukuoka City, Japan
Tel
092-642-6254
ijkseimei@jimu.kyushu-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
| 2022 | Year | 11 | Month | 07 | 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
25
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
| 2022 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056291
