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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015510
Receipt No. 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

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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
Last 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
1st 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
Institute The research project of LED life innovation, The University of Tokushima
Institute
Department

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
URL(English) https://upload.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


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