UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056559 |
|---|---|
| Receipt number | R000064633 |
| Scientific Title | Venous dilation effect of armdown after heat application at the site of peripheral intravenous catheterization in older patients: a pilot quasi-experimental study |
| Date of disclosure of the study information | 2025/01/08 |
| Last modified on | 2025/06/25 09:06:16 |
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Basic information
Public title
Venous dilation effect of armdown after heat application at the site of peripheral intravenous catheterization in older patients: a pilot quasi-experimental study
Acronym
Venous dilation effect of armdown after heat application in the forearms of older patients
Scientific Title
Venous dilation effect of armdown after heat application at the site of peripheral intravenous catheterization in older patients: a pilot quasi-experimental study
Scientific Title:Acronym
Venous dilation effect of armdown after heat application at the site of peripheral intravenous catheterization in older patients
Region
| Japan |
Condition
Condition
Older patients
Classification by specialty
| Medicine in general | Surgery in general | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the venous dilatation effect of arm-down after heat application at the site of peripheral intravenous catheterization in older patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Venous diameter
Key secondary outcomes
Venous depth
Venous assessment scale
Skin surface temperature
Medical records
Subjective evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Applying a tourniquet for 30 seconds
Interventions/Control_2
Applying a tourniquet for 30 seconds after armdown
Interventions/Control_3
Applying a tourniquet for 30 seconds after heat application
Interventions/Control_4
Armdown and applying a tourniquet for 30 seconds after heat application
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The age is older than 65 years of age.
2) The parson that a document agreement by the free was provided after enough understanding after having received enough explanation on participating to this study.
Key exclusion criteria
1) Patients who cannot fully understand the purpose of this study
2) Patients who cannot complain of thermal sensation
3) Patients with deteriorating general condition
4) Patients who have difficulty maintaining a sitting position
5) Patients who have difficulty intervening due to symptoms or treatment
6) Patients with a kidney disease
7) Patients with a peripheral arterial disease
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kae |
| Middle name | |
| Last name | Yasuda |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Fundamental nursing
Zip code
060-0812
Address
N12-W5, Kitaku, Sapporo, Hokkaido
TEL
011-706-3694
ykae0106@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kae |
| Middle name | |
| Last name | Yasuda |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Fundamental nursing
Zip code
060-0812
Address
N12-W5, Kitaku, Sapporo, Hokkaido
TEL
011-706-3694
Homepage URL
ykae0106@hs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Faculty of Health Sciences, Hokkaido University
Address
N12-W5, Kitaku, Sapporo, Hokkaido
Tel
011-706-3694
ykae0106@hs.hokudai.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
| 2025 | Year | 01 | Month | 08 | 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
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
| 2024 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 12 | Month | 25 | Day |
Last modified on
| 2025 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064633
