UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003727 |
|---|---|
| Receipt number | 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 13:35:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tanioka@medsci.tokushima-u.ac.jp
Sponsor or person
Institute
Department of Nursing Outcome Management, Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004508
