UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Psychological effects on people with mental disorder by hypersonic sounds
Title of the study (Brief title)	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	Nobuaki Morita
Organization	University of Tsukuba
Division name	Department of medicine
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
Email	nobuakim@nifty.cpm

Public contact
Name of contact person	Nobuaki Morita
Organization	University of Tsukuba
Division name	Department of medicine
Address	Laboratory of Advanced Research D,University of Tsukuba,Department of Comprehensive Human Science,1-
TEL	029-853-3099
Homepage URL
Email	nobuakim@nifty.com

Sponsor
Institute	University of Tsukuba
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 07 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020833