UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048289 |
|---|---|
| Receipt number | R000055025 |
| Scientific Title | Effects of Various Methods of Holding Intramuscular Injection Sites in the Deltoid Region on Subcutaneous Tissue and Muscle Thickness: Crossover study |
| Date of disclosure of the study information | 2022/08/10 |
| Last modified on | 2023/12/13 10:53:45 |
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Basic information
Public title
Effects of Various Methods of Holding Intramuscular Injection Sites in the Deltoid Region on Subcutaneous Tissue and Muscle Thickness
Acronym
Effects of Various Methods of Holding Intramuscular Injection Sites in the Deltoid Region on Subcutaneous Tissue and Muscle Thickness
Scientific Title
Effects of Various Methods of Holding Intramuscular Injection Sites in the Deltoid Region on Subcutaneous Tissue and Muscle Thickness: Crossover study
Scientific Title:Acronym
Effects of Various Methods of Holding Intramuscular Injection Sites in the Deltoid Region on Subcutaneous Tissue and Muscle Thickness
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of various methods of holding the muscle injection site to the deltoid region on subcutaneous tissue and muscle thickness
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Thickness of subcutaneous tissue and muscle (ultrasound imaging)
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
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Implement four types of holding methods:
(1) grab the deltoid muscle
Interventions/Control_2
(2) grab the skin
Interventions/Control_3
(3) stretch the skin
Interventions/Control_4
(4) grab the skin after stretching
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Healthy subjects
Key exclusion criteria
1. Subjects who have deltoid muscle disease in either shoulder
2. Subjects with skin abnormalities in the deltoid muscle of either shoulder
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Maeda |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Health Sciences
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL
0338191211
k-maeda@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Maeda |
Organization
Tokyo Metropolitan University
Division name
Graduate School of Health Sciences
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL
0338191211
Homepage URL
k-maeda@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan University
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
Tokyo Metropolitan University
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
Tel
0338191211
rinri-hs@tmu.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
| 2022 | Year | 08 | 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
30
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
| 2022 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 07 | Month | 05 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055025
