UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of music on stress and pain in children receiving vaccine: An exploratory clinical trials
Title of the study (Brief title)	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	Ikuko Sobue
Organization	Hiroshima University
Division name	Graduate School of Biomedical & Health Sciences
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	Yui Yamane
Organization	Hiroshima University
Division name	Graduate School of Biomedical & Health Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027159