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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name