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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003727
Receipt No. R000004508
Scientific Title Research on nursing technique in intramuscular injection
Date of disclosure of the study information 2010/06/10
Last modified on 2018/06/20

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Basic information
Public title Research on nursing technique in intramuscular injection
Acronym Research on technique in IM injection
Scientific Title Research on nursing technique in intramuscular injection
Scientific Title:Acronym 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
1st name
Middle name
Last name Tetsuya Tanioka
Organization Institute of Health Biosciences, The University of Tokushima Graduate School
Division name Department of Nursing Management
Zip code
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
1st name
Middle name
Last name Tetsuya Tanioka
Organization Tokushima University Graduate School
Division name Department of Nursing Outcome Management, Institute of Biomedical Sciences
Zip code
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)

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 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

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 Preinitiation
Date of protocol fixation
2010 Year 06 Month 10 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000004508

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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