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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035016
Receipt No. R000039925
Scientific Title State effect of short-term meditation on meditation novices: A neuroscientific study
Date of disclosure of the study information 2018/11/27
Last modified on 2019/05/29

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Basic information
Public title State effect of short-term meditation on meditation novices: A neuroscientific study
Acronym State effect of short-term meditation on neural bases
Scientific Title State effect of short-term meditation on meditation novices: A neuroscientific study
Scientific Title:Acronym State effect of short-term meditation on neural bases
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the acute effect of the single session meditation for inexperienced person on the cognitive function from a viewpoint of neural basis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in cognitive function and functional connectivity before and after meditation
Key secondary outcomes The Two-Dimensional Mood Scale
Quality of meditation
Degree of mind wandering
The Stanford Sleepiness Scale
Effort of meditation
Mindful Attention Awareness Scale
the Mind Wandering Questionnaire
Big Five Scale
Raven's advanced progressive matrix test
Epistemic Curiosity Scale
The trust scale

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Su-soku meditation
Interventions/Control_2 Sham meditation
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
30 years-old >=
Gender Male and Female
Key inclusion criteria healthy 20-30 age right-handed Japanese adults who are inexperienced of meditation.
Key exclusion criteria Person with a history of mental illness
Pregnant
Left-handed person
Person with meditation experience
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ryuta
Middle name
Last name Kawashima
Organization Institute of Development, Aging and Cancer (IDAC), Tohoku University
Division name Department of Functional Brain Imaging
Zip code 980-8575
Address 4-1 Seiryocho, Aobaku, Sendai, Japan
TEL 022-717-7988
Email ryuta@tohoku.ac.jp

Public contact
Name of contact person
1st name Shigeyuki
Middle name
Last name Ikeda
Organization Institute of Development, Aging and Cancer (IDAC), Tohoku University
Division name Ubiquitous Sensing
Zip code 980-8575
Address 4-1 Seiryocho, Aobaku, Sendai, Japan
TEL 022-717-7988
Homepage URL
Email shigeyuki.ikeda.e2@tohoku.ac.jp

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

Funding Source
Organization Institute of Development, Aging and Cancer, Tohoku University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku University School of Medicine
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel 022-717-8007
Email med-kenkyo@grp.tohoku.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

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 27 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
2018 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2018 Year 11 Month 27 Day
Last modified on
2019 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039925

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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