UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052833 |
|---|---|
| Receipt number | R000060295 |
| Scientific Title | A Study of Behavioral Characteristics of Children with Simulated Intravenous Infusion Fixation |
| Date of disclosure of the study information | 2023/11/17 |
| Last modified on | 2023/11/17 23:52:08 |
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Basic information
Public title
A Study of Behavioral Characteristics of Children with Simulated Intravenous Infusion Fixation
Acronym
A Study of Behavioral Characteristics of Children with Simulated Intravenous Infusion Fixation
Scientific Title
A Study of Behavioral Characteristics of Children with Simulated Intravenous Infusion Fixation
Scientific Title:Acronym
A Study of Behavioral Characteristics of Children with Simulated Intravenous Infusion Fixation
Region
| Japan |
Condition
Condition
Healthy 3-4 year old infants with no previous IV therapy within the past year
Classification by specialty
| Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify behavioral characteristics during simulated IV immobilization in healthy children 3-4 years old, and to examine better IV immobilization methods for children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Restriction of the child's movement during simulated IV immobilization
Key secondary outcomes
How to remove the IV fixation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
video viewing without simulated IV fixation >> video viewing with simulated IV fixation >> block playing with simulated IV fixation >> block playing without simulated IV fixation
Interventions/Control_2
without splint fixation, with splint fixation
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
| 3 | years-old | <= |
Age-upper limit
| 4 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy children
Key exclusion criteria
No previous IV therapy within the past year
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Takubo |
Organization
Tokyo Healthcare University
Division name
Chiba Faculty of Nursing
Zip code
273-8710
Address
1-1042-2 Kaijinchou-nishi, Funabashi, Chiba, JAPAN
TEL
047-495-7751
y-takubo@thcu.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Takubo |
Organization
Tokyo Healthcare University
Division name
Chiba Faculty of Nursing
Zip code
273-8710
Address
1-1042-2 Kaijinchou-nishi, Funabashi, Chiba, JAPAN
TEL
047-495-7751
Homepage URL
y-takubo@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
Yumiko Takubo
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Healthcare University Ethics Committee on Human Research
Address
4-1-17 Higashigotanda, Shinagawa-ku, Tokyo, JAPAN
Tel
03-5421-7656
kenkyo@thcu.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
| 2023 | Year | 11 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 11 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060295
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
