UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050916 |
|---|---|
| Receipt number | R000055580 |
| Scientific Title | Impact of the Warm Compress Method Conducted by Nurses Before Venipuncture on Blood Nitric Oxide Concentration |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2026/05/22 14:29:05 |
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Basic information
Public title
Impact of the Warm Compress Method Conducted by Nurses Before Venipuncture on Blood Nitric Oxide Concentration
Acronym
Impact of the Warm Compress Method Conducted by Nurses Before Venipuncture on Blood Nitric Oxide Concentration
Scientific Title
Impact of the Warm Compress Method Conducted by Nurses Before Venipuncture on Blood Nitric Oxide Concentration
Scientific Title:Acronym
Impact of the Warm Compress Method Conducted by Nurses Before Venipuncture on Blood Nitric Oxide Concentration
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine whether the warm compress, a nursing technique that promotes vasodilatation, has an effect on the increase in the vasodilator Nitric Oxide.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nitric Oxide
Key secondary outcomes
cross-sectional area of vein
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Warm forearms with a 40 degrees Celsius heat pack for 5 minutes
Interventions/Control_2
No interventions
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy males and females from 20 to 70 years old
Key exclusion criteria
Experience with vagal response or vagal reflex
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Shotaro |
| Middle name | |
| Last name | Koike |
Organization
Aomori University of Health and Welfare
Division name
Department of nursing
Zip code
0308505
Address
1-58 Mase, Hamadate, Aomori
TEL
0177652141
s_koike@auhw.ac.jp
Public contact
Name of contact person
| 1st name | Shotaro |
| Middle name | |
| Last name | Koike |
Organization
Aomori University of Health and Welfare
Division name
Department of nursing
Zip code
0308505
Address
1-58 Mase, Hamadate, Aomori
TEL
0177652141
Homepage URL
s_koike@auhw.ac.jp
Sponsor or person
Institute
Aomori University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Aomori University of Health and Welfare
Address
1-58 Mase, Hamadate, Aomori
Tel
0177652141
s_koike@auhw.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 | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://journals.lww.com/journalofinfusionnursing/fulltext/2025/03000/impact_of_the_warm_compress_me
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/journalofinfusionnursing/fulltext/2025/03000/impact_of_the_warm_compress_me
Number of participants that the trial has enrolled
18
Results
Among the 19 participants (7 men and 12 women; mean age: 42.6 years), significant differences were observed in skin temperature (32.05 versus 39.40), vein cross-sectional area (11.4 mm versus 14.8 mm2), and blood NO concentration (12.45 and 11.18) pre- and post-intervention, possibly because the action of blood NO on vascular smooth muscle cells was promoted, leading to blood NO consumption.
Results date posted
| 2026 | Year | 05 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were 19 participants: 7 men and 12 women. The mean age was 42.6 years.
Participant flow
During the recruitment period, 19 applications were received from eligible participants. No individual call was made to recruit one more participant because of the possibility of coercion. Moreover, the number of participants was very close to the calculated sample size, so the authors considered this study feasible. This study involved blood sampling; therefore, to minimize the risk of bleeding, individuals receiving therapy with anticoagulants and antiplatelet drugs were excluded, as well as those who had experienced a vasovagal reflex caused by pain during blood collection in the past. Those with vascular-related diseases affecting vasodilation, kidney disease, and diabetes and those using antihypertensive medications were also excluded
Adverse events
None
Outcome measures
Vessel cross-sectional area, Blood nitric oxide
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 24 | Day |
Last modified on
| 2026 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055580
