UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037841 |
|---|---|
| Receipt number | R000043143 |
| Scientific Title | The effectiveness of external cold and vibration for pain relief of vaccination in children |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2020/03/13 16:49:18 |
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Basic information
Public title
The effectiveness of external cold and vibration for pain relief of vaccination in children
Acronym
The effectiveness of external cold and vibration for pain relief of vaccination in children
Scientific Title
The effectiveness of external cold and vibration for pain relief of vaccination in children
Scientific Title:Acronym
The effectiveness of external cold and vibration for pain relief of vaccination in children
Region
| Japan |
Condition
Condition
Healthy child
Classification by specialty
| Pediatrics | Nursing | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the pain-relieving effect of vibration cold stimulation during vaccination in children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The degree of pain
1.Wong-Baker FACES Pain Rating Scale
2.Face, Legs, Activity, Cry, Consolability Behavioral Scale
Key secondary outcomes
Satisfaction with external vibration cool stimulation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The subject is continuously given vibration and cold stimulation 30 seconds before vaccination until the end of vaccination.
Interventions/Control_2
Control arm
Inoculate the influenza vaccine as usual.
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
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A child who has received the influenza vaccine and has obtained consent for research.
Key exclusion criteria
Abnormal pain perception.
The explanation is not comprehensible understood.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Sagawa |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Comprehensive Development Nursing
Zip code
0600812
Address
Kita12,Nishi5,Kita-ku,Sapporo, Hokkaido
TEL
011-706-2822
t-sagawa@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Sagawa |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Comprehensive Development Nursing
Zip code
0600812
Address
Kita12,Nishi5,Kita-ku,Sapporo, Hokkaido
TEL
011-706-2822
Homepage URL
t-sagawa@hs.hokudai.ac.jp
Sponsor or person
Institute
Faculty of Health Sciences, Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Health Sciences, Hokkaido University
Address
Kita12,Nishi5,Kita-ku,Sapporo, Hokkaido
Tel
011-716-2111
shomu@hs.hokudai.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
| 2019 | Year | 10 | Month | 01 | 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
| 2019 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 08 | Month | 29 | Day |
Last modified on
| 2020 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043143
