UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022883
Receipt number R000026375
Scientific Title Effect of the occipital cold compress on the body
Date of disclosure of the study information 2016/06/25
Last modified on 2017/08/17 15:43:06

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Basic information

Public title

Effect of the occipital cold compress on the body

Acronym

Effect of the occipital cold compress on the body

Scientific Title

Effect of the occipital cold compress on the body

Scientific Title:Acronym

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

1st name
Middle name
Last name Matsushita Naoko

Organization

kio University Grsduate School of Health Science

Division name

kio University Grsduate School of Health Science

Zip code


Address

4-2-2 Umaminaka Koryocho ,Kitakaturagigun,Nara

TEL

0745-54-1601

Email

matsushita@kansai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Matsushita Naoko

Organization

kio University Grsduate School of Health Science

Division name

kio University Grsduate School of Health Science

Zip code


Address

4-2-2 Umaminaka Koryocho ,Kitakaturagigun,Nara

TEL

0745-54-1601

Homepage URL


Email

matsushita@kansai.ac.jp


Sponsor or person

Institute

kio University Grsduate School of Health Science

Institute

Department

Personal name



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)



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

2016 Year 06 Month 25 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

2016 Year 06 Month 25 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026375


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name