UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002517 |
|---|---|
| Receipt number | R000003078 |
| Scientific Title | Study of provide effect of entertainment in cognitive function |
| Date of disclosure of the study information | 2009/09/17 |
| Last modified on | 2018/09/30 11:19:50 |
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Basic information
Public title
Study of provide effect of entertainment in cognitive function
Acronym
RCT on stress reduction effect of entertainment
Scientific Title
Study of provide effect of entertainment in cognitive function
Scientific Title:Acronym
RCT on stress reduction effect of entertainment
Region
| Japan |
Condition
Condition
healthy adult man and a healthy adult women
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the stress reduction efficacy by entertainment for a work worker.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Brain structure measured by MRI
2.Evaluation of the cerebral blood flow in resting conditions
3.Diffusion tensor imaging measured by MRI
4.Cortisol concentration in a spittle
5.Number of NK cells in a peripheral blood
6.NK-cell activity in a peripheral blood
4 or 8 weeks after a vital involvement start.
Key secondary outcomes
1.GHQ score
2.J-SACL score
3.WAIS-3 score
4 or 8 weeks after a vital involvement start.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1-month intervention by a biofeedback game, afterword 1-month service intervention.
Intervention by a biofeedback game plays once a day, and five minutes about once in principle.
Interventions/Control_2
1-month non-intervention, afterword 1-month intervention by a biofeedback game.
Intervention by a biofeedback game plays once a day, and five minutes about once in principle.
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
| 55 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Dwelling place: Sendai and the Sendai environs
2.Age:20-55
3.People who feel the stress of the work and who are working now
4.Right-handed person
Key exclusion criteria
1.Person whom has metal in the body(ex. a pacemaker, an aneurysm clip)
2.Person without medical history of the cerebral nerve disease
3.Person without medical history such as high blood pressure, the diabetes
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuka KOTOZAKI |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Functional brain imaging
Zip code
Address
Seiryo-machi 4-1, Aoba-ku Sendai,
TEL
022-717-7988
kotoyuka@idac.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Kotozaki |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Functional brain imaging
Zip code
Address
4-1, Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7988
Homepage URL
kotoyuka@idac.tohoku.ac.jp
Sponsor or person
Institute
Institute of Development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Self funding
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
東北大学加齢医学研究所（宮城県）、仙台星陵クリニック（宮城県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | 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
| 2009 | Year | 09 | Month | 17 | Day |
Last modified on
| 2018 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003078
| 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 |
