UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052863 |
|---|---|
| Receipt number | R000060263 |
| Scientific Title | Effectiveness of Using Kaleidoscope for Reducing Perceptive Pain in Children Venipuncture Procedure: A Systematic Review and Meta-Analysis |
| Date of disclosure of the study information | 2023/11/23 |
| Last modified on | 2023/11/21 23:44:54 |
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Basic information
Public title
Effectiveness of Using Kaleidoscope for Reducing Perceptive Pain in Children Venipuncture Procedure: A Systematic Review and Meta-Analysis
Acronym
The effects of kaleidoscope pain reduction on children undergoing venipuncture procedure: a systematic review and meta-analysis.
Scientific Title
Effectiveness of Using Kaleidoscope for Reducing Perceptive Pain in Children Venipuncture Procedure: A Systematic Review and Meta-Analysis
Scientific Title:Acronym
The effects of kaleidoscope pain reduction on children undergoing venipuncture procedure: A systematic review and meta-analysis.
Region
| Japan |
Condition
Condition
Children undergoing venipuncture procedure
Classification by specialty
| Pediatrics | Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effectiveness of distraction with kaleidoscopes in decreasing pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Children's pain
Key secondary outcomes
Children's anxiety
Children's pre and post procedure fear
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 4 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Randomized controlled trials
Studies involving participants aged 4-12 healthy children who undergoing venipuncture procedure
Using kaleidoscope as an intervention
Key exclusion criteria
Studies written in languages other than English
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Saki |
| Middle name | |
| Last name | Iwanami |
Organization
St. Luks's International University
Division name
Nursing
Zip code
104-0044
Address
10-1 Akashicho Chuo-ku Tokyo-to Japan
TEL
03-3543-6391
20bn013@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Erika |
| Middle name | |
| Last name | Ota |
Organization
St Luke s International University
Division name
Graduate school of nursing science, Global Health Nursing
Zip code
104-0044
Address
10-1 Akashicho Chuo-ku Tokyo-to Japan
TEL
03-5550-2374
Homepage URL
ota@slcn.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
N/A
Address
N/A
Tel
N/A
N/A
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 | 23 | 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
| 2023 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will examine the effects of reducing pain and anxiety by providing a kaleidoscope of distraction to children undergoing veniouncture procedure through a systematic review and meta-analysis.
Management information
Registered date
| 2023 | Year | 11 | Month | 21 | Day |
Last modified on
| 2023 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060263
