UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048308 |
|---|---|
| Receipt number | R000055054 |
| Scientific Title | Comparison of the vasodilation effect of heat application using a hot pack or towel |
| Date of disclosure of the study information | 2022/07/07 |
| Last modified on | 2023/06/12 13:05:03 |
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Basic information
Public title
Comparison of the vasodilation effect of heat application using a hot pack or towel
Acronym
Comparison of the vesodilation effect of heat application using a hot pack or towel
Scientific Title
Comparison of the vasodilation effect of heat application using a hot pack or towel
Scientific Title:Acronym
Comparison of the vasodilation effect of heat application using a hot pack or towel
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the venodilation effect of heat application using a hot pack and towel (moist or dry heat stimulation).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Venous 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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A: Applying a tourniquet for 30 seconds
Interventions/Control_2
B: After applying a hot pack for 7 minutes, 4 minutes 30 seconds of rest time and tourniquet 30 seconds
Interventions/Control_3
C: After applying a hot towel for 7 minutes, 4 minutes 30 seconds of rest time and tourniquet 30 seconds
Interventions/Control_4
D: After applying a hot towel wrapped in plastic bag for 7 minutes, 4 minutes 30 seconds of rest time and tourniquet 30 seconds
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
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy adult
Key exclusion criteria
History of cardiovascular disease
Skin problems in the target site
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | yano |
| Middle name | |
| Last name | rika |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
0600812
Address
N12-W5, Kitaku, Sapporo, Hokkaido
TEL
011-706-3323
r-yano@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | yano |
| Middle name | |
| Last name | rika |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
0600812
Address
N12-W5, Kitaku, Sapporo, Hokkaido
TEL
011-706-3323
Homepage URL
r-yano@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
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
Faculty of Health Sciences, Hokkaido University
Address
N12-W5, Kitau, Sapporo, Hokkaido
Tel
011-706-3323
r-yano@med.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
| 2022 | Year | 07 | 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
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 | 07 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 10 | 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 | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055054
