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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023582
Receipt No. 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

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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
Email 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
Email m155338@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

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
Email

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
URL(English) https://upload.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
Registered date File name


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