UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of the occipital cold compress on the body
Title of the study (Brief title)	Effect of the occipital cold compress on the body
Region	Japan

Condition
Condition	have a high tempureture or general malaise
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A study was conducted to clarify the usefulness of a cold compress applied to the occipital area
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	skin temprature skin blood flow blood ptrssure heart rate variability salivary amylas sbjective response
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	mothod A( cold compress applied ) A cold compress was applied to the occipital area for 20min. mothod B( mo cold compress applied )
Interventions/Control_2	mothod B( mo cold compress applied ) A none cold compress was applied to the occipital area for 20min. mothod A( cold compress applied )
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	40 years-old >=
Gender	Female
Key inclusion criteria	healthy femele
Key exclusion criteria	heat disease
Target sample size	12

Research contact person
Name of lead principal investigator	Matsushita Naoko
Organization	kio University Grsduate School of Health Science
Division name	kio University Grsduate School of Health Science
Address	4-2-2 Umaminaka Koryocho ,Kitakaturagigun,Nara
TEL	0745-54-1601
Email	matsushita@kansai.ac.jp

Public contact
Name of contact person	Matsushita Naoko
Organization	kio University Grsduate School of Health Science
Division name	kio University Grsduate School of Health Science
Address	4-2-2 Umaminaka Koryocho ,Kitakaturagigun,Nara
TEL	0745-54-1601
Homepage URL
Email	matsushita@kansai.ac.jp

Sponsor
Institute	kio University Grsduate School of Health Science
Institute
Department

Funding Source
Organization	kio University Grsduate School of Health Science
Organization
Division
Category of Funding Organization	Other
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 06 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 25 Day
Anticipated trial start date	2016 Year 06 Month 25 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 06 Month 25 Day
Last modified on	2017 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026375