UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053509 |
|---|---|
| Receipt number | R000061072 |
| Scientific Title | Effects of Hemostasis, Arm-Down, and Warm Compress on Venous Anger during Venipuncture in the Supine Position -Comparison of cross sectional area, distance from skin surface, and palpable degree of venous irritation |
| Date of disclosure of the study information | 2024/02/10 |
| Last modified on | 2025/01/15 16:15:35 |
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Basic information
Public title
Effects of Hemostasis, Arm-Down, and Warm Compress on Venous Anger during Venipuncture in the Supine Position
-Comparison of cross sectional area, distance from skin surface, and palpable degree of venous irritation
Acronym
Effects of venous vasodilation by the technique during venipuncture in the supine position
Scientific Title
Effects of Hemostasis, Arm-Down, and Warm Compress on Venous Anger during Venipuncture in the Supine Position
-Comparison of cross sectional area, distance from skin surface, and palpable degree of venous irritation
Scientific Title:Acronym
Effects of venous vasodilation by the technique during venipuncture in the supine position
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of antiemostatic, arm-down, and warm compress methods on venous irritation during venipuncture in the supine position by comparing the cross-sectional area, distance from the skin surface, and degree of palpable irritation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Vascular cross-sectional area
Distance from skin surface
Palpable Tension
Key secondary outcomes
a Items related to subject's background
1 Age 2 Gender 3 Blood pressure
b Items related to venous vasodilation
1 Long and short diameter of blood vessel cm 2 Palpable degree of vasodilation 3 Skin temperature
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
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
arm-down technique
Interventions/Control_2
hot compress
Interventions/Control_3
only for depletion of blood
Interventions/Control_4
at rest
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) No underlying disease (no disease currently requiring treatment). (2) No history of upper limb or shoulder surgery. (3) No limitation of range of motion of upper limb/shoulder joint (4) No allergy to metal, latex, or medical tape No allergy to metal, latex, or medical tape.
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 | yuto |
| Middle name | |
| Last name | isii |
Organization
Tokyo Healthcare University
Division name
Graduate School of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro, Tokyo
TEL
03-5779-5031
kg023003@thcu.ac.jp
Public contact
Name of contact person
| 1st name | yuto |
| Middle name | |
| Last name | ishii |
Organization
Tokyo Healthcare University
Division name
Graduate School of Nursing
Zip code
152-8558
Address
2-5-1 Higashigaoka, Meguro, Tokyo
TEL
03-5779-5031
Homepage URL
kg023003@thcu.ac.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
other
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-sho@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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
39
Results
Distance from the skin surface: There was no significant difference in distance from the skin surface for both MC and CE compared to the resting state. Tactile tension: Both MC and CE significantly increased compared to the resting state for all methods (p<.01), but there was no difference between the methods.
Results date posted
| 2025 | Year | 01 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
A recruitment flyer containing an outline of the research was distributed to eligible students. Students who saw the flyer, applied on their own initiative, and agreed to cooperate in the research were eligible for the study.
Adverse events
without
Outcome measures
Vascular cross-sectional area
Distance from skin surface
Palpable Tension
Skin temperature
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 01 | Day |
Last modified on
| 2025 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061072
