UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012872 |
|---|---|
| Receipt number | R000015040 |
| Scientific Title | Examination of the influence that nonnoxious stimulation gives for skin venipunctual pain |
| Date of disclosure of the study information | 2014/01/16 |
| Last modified on | 2017/08/11 09:06:05 |
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Basic information
Public title
Examination of the influence that nonnoxious stimulation gives for skin venipunctual pain
Acronym
Influence of nonnoxious stimulation gives for skin venipunctual pain
Scientific Title
Examination of the influence that nonnoxious stimulation gives for skin venipunctual pain
Scientific Title:Acronym
Influence of nonnoxious stimulation gives for skin venipunctual pain
Region
| Japan |
Condition
Condition
The patient that an IV line is secured
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I examine influence on boring pain by giving noninfringement stimulation before puncture as a method to relieve boring pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Using stimulation and reaction (including strain, the expression of a breathing change, limbs) at the time of a heart rate, the puncture before and after the puncture and Visual analog scal(VAS), I evaluate the pain.
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The neighborhood of puncture department of the back of hand using ten seconds paint brush after stimulation (noninfringement stimulation) the part a vein custody needle.
Interventions/Control_2
To back of hand a vein custody needle of 22G.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The one where an agreement was provided in healthy volunteers.
Key exclusion criteria
More than Physical Status 3 of the American society of anesthesiologist.
The one that has an operation career in the puncture part.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Sugiyama |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resusucitology
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2670
sugidai@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Sugiyama |
Organization
Shinshu University School of Medicineiyama
Division name
Department of Anesthesiology and Resusucitology
Zip code
Address
3-1-1 Asahi Matsumoto
TEL
0263-37-2670
Homepage URL
sugidai@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology and Resusucitology
Shinshu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 01 | Month | 16 | 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
| 2014 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 16 | Day |
Last modified on
| 2017 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015040
