UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037293 |
|---|---|
| Receipt number | R000041886 |
| Scientific Title | The effect of autogenic training on psychosomatic disorder: An exploratory study |
| Date of disclosure of the study information | 2019/07/08 |
| Last modified on | 2022/03/03 23:55:47 |
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Basic information
Public title
The effect of autogenic training on psychosomatic disorder: An exploratory study
Acronym
The effect of autogenic training on psychosomatic disorder: An exploratory study
Scientific Title
The effect of autogenic training on psychosomatic disorder: An exploratory study
Scientific Title:Acronym
The effect of autogenic training on psychosomatic disorder: An exploratory study
Region
| Japan |
Condition
Condition
psychosomatic disorder
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the autogenic training for psychosomatic disorder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Toronto Alexithymia Scale
Key secondary outcomes
somatosensory amplification scale, skin temperature, heart rate, saturation of percutaneous oxygen
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
autogenic training
Interventions/Control_2
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
outpatients for department of psychosomatic medicine, who want to join the program of autogenic training.
Key exclusion criteria
who have problems with understanding due to dementia etc.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Miyakoda |
Organization
Toho university Omori medical center
Division name
Department of psychosomatic medicine
Zip code
143-8541
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo
TEL
+81-3-3762-4151
jun-miyakoda@sakura.med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Miyakoda |
Organization
Toho university Omori medical center
Division name
Department of psychosomatic medicine
Zip code
143-8541
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo
TEL
+81-3-3762-4151
Homepage URL
jun-miyakoda@sakura.med.toho-u.ac.jp
Sponsor or person
Institute
Toho university
Institute
Department
Personal name
Funding Source
Organization
Toho university
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
Ethics committee of Toho university Omori medical center
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo
Tel
+81-3-5763-6534
omori.rinri@ext.toho-u.ac.jp
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
東邦大学医療センター大森病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 08 | 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
0
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
Terminated
Date of protocol fixation
| 2019 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 06 | Day |
Last modified on
| 2022 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041886
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
