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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name