UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039925