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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002517
Receipt No. 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

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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
Email 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
Email kotoyuka@idac.tohoku.ac.jp

Sponsor
Institute Institute of Development, Aging and Cancer, Tohoku University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003078

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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