UMIN-CTR Clinical Trial

Basic information
Public title	Influence of adjustment to indoor sound environment on children and their care takers
Acronym	Influence of adjustment to indoor sound environment on children and their care takers
Scientific Title	Influence of adjustment to indoor sound environment on children and their care takers
Scientific Title:Acronym	Influence of adjustment to indoor sound environment on children and their care takers
Region	Japan

Condition
Condition	Pervasive developmental disorders Attention deficit hyperactivity disorder Conduct disorder Healthy adults
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Acoustic materials are introduced for day rooms of psychiatric and child ward, and we observe the difference between how the staff feel before and after the installation and the change of physical and mental condition as well as the change of their reception toward the children by questionaire paper and interview.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Quesitionaire survey before the installation of Acoustic materials /1 week later / 2months later
Key secondary outcomes	Actigraph measured before the installation of Acoustic materials /1 week later Profile of mood state in Japanese before the installation of Acoustic materials /2months later

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	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	2 months installation of Acoustic materials at the day room walls. Removal of Acoustic materials after survey is adjusted with facilities.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Staff working at psychiatric and child ward,
Key exclusion criteria	nothing
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Sachiko Middle name Last name Tsuchida
Organization	Suzuka University of Medical Science
Division name	Faculty of Nursing
Zip code	5138670
Address	3500-3,Minamitamagaki-cho,Suzuka-shi,Mie-ken,Japan
TEL	059-340-0855
Email	sachiko@suzuka-u.ac.jp

Public contact
Name of contact person	1st name Sachiko Middle name Last name Tsuchida
Organization	Suzuka University of Medical Science
Division name	Faculty of Nursing
Zip code	5138670
Address	3500-3,Minamitamagaki-cho,Suzuka-shi,Mie-ken,Japan
TEL	059-340-0855
Homepage URL
Email	sachiko@suzuka-u.ac.jp

Sponsor
Institute	Suzuka University of Medical Science
Institute
Department

Funding Source
Organization	JSPS KAKENHI
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Ethics Review Committee,Suzuka University of Medical Science
Address	3500-3,Minamitamagaki-cho,Suzuka-shi,Mie-ken,Japan
Tel	059-373-7831
Email	isobe@suzuka-u.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	三重県立こども心身発達医療センター（三重県）

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 20 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	25
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	2020 Year 07 Month 28 Day
Date of IRB	2020 Year 07 Month 31 Day
Anticipated trial start date	2020 Year 09 Month 20 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 08 Month 31 Day
Date trial data considered complete	2021 Year 08 Month 31 Day
Date analysis concluded	2021 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 08 Month 21 Day
Last modified on	2022 Year 02 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047385