UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017985 |
|---|---|
| Receipt number | R000020833 |
| Scientific Title | Psychological effects on people with mental disorder by hypersonic sounds |
| Date of disclosure of the study information | 2015/07/03 |
| Last modified on | 2017/12/20 12:22:20 |
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Basic information
Public title
Psychological effects on people with mental disorder by hypersonic sounds
Acronym
hypersonic effects on mental disorder
Scientific Title
Psychological effects on people with mental disorder by hypersonic sounds
Scientific Title:Acronym
hypersonic effects on mental disorder
Region
| Japan |
Condition
Condition
Neurotic,Stress-related and Somatoform Disorder,Mood Disorder,Sustance Use Disorder
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry | Not applicable |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm that hypersonic sound have effects to make stress-related symptoms of mental deasease persons reduce and feasibility of psychotherapy using hypersonic
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HRV(Heart Rate Variability)
Psychological test(K6,IES-R,POMS,Visual analogue scale of subjective emotional state)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention condition is exposure to sounds with hypeersonic during 4 sessons of counseling.The sounds is natural sounds including singing ofinsects and birds,and voices of wind and etc. recorded in forest.
Interventions/Control_2
The condition is exposure to sounds without hypersonic that is natural sounds from which a hypersonic component was removed.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.mentally disordered persons who suffer stress symptoms
2.The person who has a medical treatment at medical agencies and rehabilitation facilities
3.The person who is receiving counseling or hopes for that
4.The person who consented about research collaboration
Key exclusion criteria
1.The person who can't use counseling continually for mental disorder.
2.The person who tend to do problematic beaviors such as self-injury or violence.
3.The person who can't understand a objects and procedures of this study because of mental and/oritellectul problems.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuaki Morita |
Organization
University of Tsukuba
Division name
Department of medicine
Zip code
Address
Laboratory of Advanced Research D, University of Tsukuba, Department of Comprehensive Human Science, 1-1-1,Tennodai,Tsukuba, Ibraki,305-8577,Japan
TEL
029-853-3099
nobuakim@nifty.cpm
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuaki Morita |
Organization
University of Tsukuba
Division name
Department of medicine
Zip code
Address
Laboratory of Advanced Research D,University of Tsukuba,Department of Comprehensive Human Science,1-
TEL
029-853-3099
Homepage URL
nobuakim@nifty.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Address
Tel
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
| 2015 | Year | 07 | Month | 03 | 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
| 2015 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 19 | Day |
Last modified on
| 2017 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020833
