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
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
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
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
