UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046289 |
|---|---|
| Receipt number | R000052823 |
| Scientific Title | Effectiveness of listening to music on hypersensitivity of autism spectrum disorder - Development of audio equipment and clinical research - |
| Date of disclosure of the study information | 2021/12/06 |
| Last modified on | 2022/03/16 14:55:43 |
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Basic information
Public title
Effectiveness of listening to music on hypersensitivity of autism spectrum disorder
- Development of audio equipment and clinical research -
Acronym
Effectiveness of listening to music on hypersensitivity of autism spectrum disorder
- Development of audio equipment and clinical research -
Scientific Title
Effectiveness of listening to music on hypersensitivity of autism spectrum disorder
- Development of audio equipment and clinical research -
Scientific Title:Acronym
Effectiveness of listening to music on hypersensitivity of autism spectrum disorder
- Development of audio equipment and clinical research -
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to reveal the effect of passive music therapy on hypersensitivity and psychiatric symptoms in ASD cases and associated behavioral problems.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All subjects assess their hypersensitivity using the sensory profile a total of two times: once before and once after the music intervention period.
Key secondary outcomes
Aberrant Behavior Checklist-Community
Face Rating Scale
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
| Behavior,custom | Other |
Interventions/Control_1
Develop audio equipment that can simultaneously evaluate mental symptoms and play music. The clinical study will ask subjects to listen to music when they experience psychiatric symptoms in their daily lives for 4 weeks, and evaluate hypersensitivity, behavioral problems, and psychiatric symptoms before and after listening to music.
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
| 6 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Those who are 6 to 15 years old
(2)Those who have been admitted to the psychiatric outpatient department of Tokai University School of Medicine with a diagnosis of ASD
(3)Those who have a slight intellectual impairment or no intellectual impairment of IQ50 or greater
(4)Those who have received sufficient explanation for participation in this study and who have obtained written consent from their parents and their will
Key exclusion criteria
(1)Persons living in facilities
(2)IQ49 or less
(3)Other persons who are deemed inappropriate by the supervisor or the research supervisor
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Yamamoto |
Organization
Tokai University
Division name
Department of Psychiatry Tokai University School of Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara City, Kanagawa, JAPAN
TEL
0463-93-1121
key@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Ami |
| Middle name | |
| Last name | Yamasato |
Organization
Tokai University
Division name
Department of Psychiatry Tokai University School of Medicine
Zip code
259-1193
Address
143 Shimokasuya, Isehara City, Kanagawa, JAPAN
TEL
0463-93-1121
Homepage URL
ami.yamasato@gmail.com
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Tokai University
Address
143 Shimokasuya, Isehara City, Kanagawa, JAPAN
Tel
0463-93-1121 (3446)
tokai-rinsho@ml.tokai-u.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
| 2021 | Year | 12 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 06 | Day |
Last modified on
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052823
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
