UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on nursing technique in intramuscular injection
Title of the study (Brief title)	Research on technique in IM injection
Region	Japan

Condition
Condition	Schizophrenia
Classification by specialty	Psychiatry Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	IM injection that the nurse injects the patient with schizophrenia is injected into gluteus medius muscle is evaluated with echography. Relation between body mass index, sebum thickness, and the blood data which becomes the clinical criterion of the assessment is clarified. The difference of the injection part reaction is confirmed in non-echography group and the echography group. The relation between therapeutic effect and quality of life by logn-acting injectable risperidone is evaluated.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The difference of injection site reaction will be evaluated in every two weeks in non-echography group and the echography group. Whether risperidone has been correctly injected into subfascial is evaluated by echography in both groups a two weeks later.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	The difference of injection site reaction is confirmed in non-echography group and the echography group.
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with schizophrenia according to DSM-4 (Diagnostic and Statistical Manual of Mental Disorders, Forth Edition; American Psychiatric Association, 1994) and who required treatment with long-acting risperidone, were eligible for inclusion in the study.
Key exclusion criteria	Patients with any type of substance abuse or with other organic psychiatric diagnoses were excluded.
Target sample size	80

Research contact person
Name of lead principal investigator	Tetsuya Tanioka
Organization	Institute of Health Biosciences, The University of Tokushima Graduate School
Division name	Department of Nursing Management
Address	3-18, Kuramoto-cho, Tokushima 770-8503, Japan
TEL	088-633-9021
Email	tanioka@medsci.tokushima-u.ac.jp

Public contact
Name of contact person	Tetsuya Tanioka
Organization	Tokushima University Graduate School
Division name	Department of Nursing Outcome Management, Institute of Biomedical Sciences
Address	3-18-15 Kuramoto-cho, Tokushima 770-8509, Japan
TEL	088-633-9021
Homepage URL
Email	tanioka@medsci.tokushima-u.ac.jp

Sponsor
Institute	Department of Nursing Outcome Management, Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department

Funding Source
Organization	JANSSEN PHARMACEUTICAL K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	徳島県立中央病院（徳島県）, 藤井病院（徳島県）

Other administrative information
Date of disclosure of the study information	2010 Year 06 Month 10 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2010 Year 06 Month 10 Day
Anticipated trial start date	2010 Year 07 Month 01 Day
Last follow-up date	2010 Year 10 Month 01 Day
Date of closure to data entry	2012 Year 07 Month 01 Day
Date trial data considered complete	2013 Year 07 Month 01 Day
Date analysis concluded	2018 Year 03 Month 31 Day

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

Management information
Registered date	2010 Year 06 Month 08 Day
Last modified on	2018 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004508