UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of venodilation technique for peripheral intravenous cannulation(the effect of thermal stimulus)
Title of the study (Brief title)	Effect of venodilation techinique using thermal stimulus
Region	Japan

Condition
Condition	health general people
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of venodilation technique using thermal stimulus
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	vein area after intervention (application of heat stimulus for 15 minutes and tourniquet for 30 seconds)
Key secondary outcomes	vein shortest and longest diameter after intervention (application of heat stimulus for 15 minutes and tourniquet for 30 seconds) skin temperature on intervention side after intervention body temperature, systolic blood pressure and diastolic blood pressure on non-intervention side arm after the intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	application of heat pack for 15 minutes and tourniquet for 30 seconds
Interventions/Control_2	application of sham treatment and tourniquet tourniquet for 30 seconds
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	healthy adult
Key exclusion criteria	1)receiving treatment for skin disease 2)a wound or eczema at the target site
Target sample size	70

Research contact person
Name of lead principal investigator	Tomoko Inoue
Organization	Graduate school of medicine Osaka University
Division name	Division of health science
Address	Graduate school of medicine Osaka University
TEL	06-6879-2526
Email	t-inoue@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person	Tomoko Inoue
Organization	Graduate school of medicine Osaka University
Division name	Division of health science
Address	1-7 Yamadaoka, Suita, Osaka
TEL	06-6879-2526
Homepage URL
Email	t-inou@sahs.med.osaka-u.ac.jp

Sponsor
Institute	Graduate school of medicine Osaka University
Institute
Department

Funding Source
Organization	Japan society for promotion of Science(JSPS)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 02 Month 19 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 02 Month 03 Day
Anticipated trial start date	2016 Year 02 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 19 Day
Last modified on	2017 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024353