UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023582 |
|---|---|
| Receipt number | R000027159 |
| Scientific Title | Effect of music on stress and pain in children receiving vaccine: An exploratory clinical trials |
| Date of disclosure of the study information | 2016/08/10 |
| Last modified on | 2017/02/24 15:32:04 |
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Basic information
Public title
Effect of music on stress and pain in children receiving vaccine: An exploratory clinical trials
Acronym
Effect of music on stress and pain in children receiving vaccine: An exploratory clinical trials
Scientific Title
Effect of music on stress and pain in children receiving vaccine: An exploratory clinical trials
Scientific Title:Acronym
Effect of music on stress and pain in children receiving vaccine: An exploratory clinical trials
Region
| Japan |
Condition
Condition
Influenza vaccine
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine an effect of the music on stress and pain of the child in the vaccination for exploring
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Saliva amylase of the child
Wong-Baker Face Scale of the child
Key secondary outcomes
Pulse of the child
SpO2 of the child
Saliva amylase of the parent who goes with a vaccination
STAI of the parent who goes with a vaccination
Questionnaire about the basic information of the child
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Music listening 35min
Interventions/Control_2
Standard care 35min
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
| 5 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.The child who receives an influenza vaccine
(1)5-year-old and 6-year-old preschool child who receive only an influenza vaccine
(2)The child who gets permission to receive an influenza vaccination from a doctor
(3)The child who gets a consent from parents for the documentary participation in this study
2.Adult who accompanies for a vaccine
(1)Parents and grandparents 20 years or older who accompany for an influenza vaccine of the child
(2)The person who receives a consent for the documentary participation in this study
Key exclusion criteria
1.The child who receives an influenza vaccine
(1)The child who is given an analgesic drug beforehand
(2)The child with a hearing loss and the visual defects
(3)The child with mental disabilities and the developmental deformity
(4)The child whom a doctor disqualified for this study
2.Adult who accompanies for a vaccine
(1)The person whom a doctor disqualified for this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuko Sobue |
Organization
Hiroshima University
Division name
Graduate School of Biomedical & Health Sciences
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL
082-257-5370
sobue@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yui Yamane |
Organization
Hiroshima University
Division name
Graduate School of Biomedical & Health Sciences
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL
082-257-5370
Homepage URL
m155338@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Muraki Pediatric clinic
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
むらき小児科（広島県）
Other administrative information
Date of disclosure of the study information
| 2016 | 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
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
| 2016 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 10 | Day |
Last modified on
| 2017 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027159
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
