UMIN-CTR Clinical Trial

Basic information
Public title	A quasi-experimental study on effects to prevent occurrence of induration of intramuscular injection site by the hot compress
Acronym	A quasi-experimental study on effects to prevent occurrence of induration of intramuscular injection site by the hot compress
Scientific Title	A quasi-experimental study on effects to prevent occurrence of induration of intramuscular injection site by the hot compress
Scientific Title:Acronym	A quasi-experimental study on effects to prevent occurrence of induration of intramuscular injection site by the hot compress
Region	Japan

Condition
Condition	Healthy person with no disease
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine effects to prevent occurrence of induration of intramuscular injection site by the hot compress on the buttocks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	tissue blood flow (StO2, oxyHb, deoxyHb, totalHb)
Key secondary outcomes	skin temperature, skin blood flow, temperature of rectum, tympanic temperature, muscle hardness, autonomic nerve activity index, skin reaction in the site of the hot compress, degree of comfort and unpleasantness by the hot compress

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	We use the hot pack on the one side of the buttock for 15 minutes.
Interventions/Control_2
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	Not applicable
Gender	Female
Key inclusion criteria	healthy person, person who agrees to participate this study
Key exclusion criteria	person with skin diseases and the induration of the injection site in the buttocks
Target sample size	7

Research contact person
Name of lead principal investigator	1st name Yoshie Middle name Last name Hara
Organization	University of Human Environments Graduate School of Nursing
Division name	Doctor of Nursing Programs
Zip code	474-0035
Address	3-220, Ebata-cho, Obu-city, Aichi, Japan
TEL	0562-43-0701
Email	dn15008@uhe.ac.jp

Public contact
Name of contact person	1st name Yoshie Middle name Last name Hara
Organization	University of Human Environments Graduate School of Nursing
Division name	Doctor of Nursing Programs
Zip code	474-0035
Address	3-220, Ebata-cho, Obu-city, Aichi, Japan
TEL	0562-43-0701
Homepage URL
Email	dn15008@uhe.ac.jp

Sponsor
Institute	University of Human Environments Graduate School of Nursing
Institute
Department

Funding Source
Organization	Japanese Society of Nursing Art and Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	the Institutional Review Board at the University of Human Environments
Address	3-220, Ebata-cho, Obu-city, Aichi, Japan
Tel	0562-43-0701
Email	m-oda@uhe.ac.jp

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	2017 Year 04 Month 18 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	2017 Year 01 Month 30 Day
Date of IRB	2016 Year 12 Month 01 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 04 Month 18 Day
Last modified on	2019 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030994