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
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
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
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
