UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015510
Receipt number R000017891
Scientific Title Investigation of efficacy in autogenic training supporting-system by light-emitting diode
Date of disclosure of the study information 2014/11/01
Last modified on 2014/10/14 14:38:09

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Basic information

Public title

Investigation of efficacy in autogenic training supporting-system by light-emitting diode

Acronym

Investigation of efficacy in autogenic training supporting-system by light-emitting diode

Scientific Title

Investigation of efficacy in autogenic training supporting-system by light-emitting diode

Scientific Title:Acronym

Investigation of efficacy in autogenic training supporting-system by light-emitting diode

Region

Japan


Condition

Condition

Healthy but stressful adults

Classification by specialty

Psychosomatic Internal Medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify that whether the LED light - guided autogenic training is more effective than common autogenic training methods (guided by voice and sounds).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Sequential changes of palm temperature, finger plethysmogram, and salivary amylase activity during autogenic training.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

At first, subject are carried out Kraepelin test for indcution of sympathetic nerve exitation (30 min). And then, the subject carried out Autogenic training (The Breathing Warm-up to Phase 2: Warmth) with the guide of voice. The training duration of each pahse is set at 2 min.

Interventions/Control_2

At first, subject are carried out Kraepelin test for indcution of sympathetic nerve exitation (30 min). And then, the subject carried out Autogenic training (The Breathing Warm-up to Phase 2: Warmth) with the guide of LED light. The training duration of each pahse is set at 2 min.

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

18 years-old <=

Age-upper limit

60 years-old >=

Gender

Male

Key inclusion criteria

A healthy adult male subject.

Key exclusion criteria

Subject whcih have clear nervous and cardiovascular disease excludes from this study.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuyoshi Kitaoka

Organization

Institute of Health Biosciences, The University of Tokushima Graduate School

Division name

Department of Physiology

Zip code


Address

3-18-15 Kuramoto-cho, Tokushima city, Tokushima, Japan

TEL

088-633-9258

Email

kitaoka@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takahiro Emoto

Organization

Institute of Technology and Science, The University of Tokushima Graduate School

Division name

Division of Life System

Zip code


Address

2-1 Minami Josanjima-cho, Tokushima city, Tokushima, Japan

TEL

088-656-7476

Homepage URL


Email

emoto@ee.tokushima-u.ac.jp


Sponsor or person

Institute

The research project of LED life innovation, The University of Tokushima

Institute

Department

Personal name



Funding Source

Organization

The Mental Health Okamoto Memorial Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

2014 Year 11 Month 01 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

2014 Year 10 Month 20 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 23 Day

Last modified on

2014 Year 10 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017891


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name