UMIN-CTR Clinical Trial

Basic information
Public title	Stress caused by change evaluation of the saliva amylase level of the child by the story-telling of the picture book
Acronym	Stress caused by change evaluation of the saliva amylase level of the child by the story-telling of the picture book
Scientific Title	Stress caused by change evaluation of the saliva amylase level of the child by the story-telling of the picture book
Scientific Title:Acronym	Stress caused by change evaluation of the saliva amylase level of the child by the story-telling of the picture book
Region	Japan

Condition
Condition	Seriously ill mind and body child with a disability
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	I draw power to grow up that the child of the severe mind and body disorder by the hypoxia-related brain fever possessed and clarify the policy to the relation of a child and the family to promote the growth development
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Saliva amylase level
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	A period of the intervention: Three months
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	3 years-old <=
Age-upper limit	6 years-old >=
Gender	Male and Female
Key inclusion criteria	Seriously ill mind and body child with a disability after the hypoxia-related brain fever
Key exclusion criteria	The child who reads the picture book
Target sample size	5

Research contact person
Name of lead principal investigator	1st name masataka Middle name Last name habata
Organization	Wakayama Medical University
Division name	Health School of Nursing
Zip code	641-0011
Address	580, Mikazura, Wakayama-shi
TEL	073-446-6700
Email	m-habata@wakayama-med.ac.jp

Public contact
Name of contact person	1st name masataka Middle name Last name habata
Organization	Wakayama Medical University
Division name	Health School of Nursing
Zip code	641-0011
Address	580, Mikazura, Wakayama-shi
TEL	073-446-6700
Homepage URL
Email	m-habata@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Wakayama Medical University
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	Wakayama Medical University
Address	580, Mikazura, Wakayama-shi
Tel	073-446-6700
Email	m-habata@wakayama-med.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 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	Preinitiation
Date of protocol fixation	2019 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date	2019 Year 10 Month 10 Day
Last follow-up date	2020 Year 10 Month 01 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 10 Month 03 Day
Last modified on	2019 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043517