UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041504
Receipt number R000047385
Scientific Title Influence of adjustment to indoor sound environment on children and their care takers
Date of disclosure of the study information 2020/09/20
Last modified on 2022/02/21 09:13:43

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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 or person

Institute

Suzuka University of Medical Science

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047385


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name