UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035016 |
|---|---|
| Receipt number | 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 | 2019/11/28 15:50:51 |
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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
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
shigeyuki.ikeda.e2@tohoku.ac.jp
Sponsor or person
Institute
Department of Ubiquitous Sensing, Institute of Development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
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
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
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
| 2018 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 17 | Day |
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 | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039925
| 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 |
