UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034888
Receipt number R000039772
Scientific Title The Duration of state effect of Su-soku meditation on cognitive functions.
Date of disclosure of the study information 2018/11/14
Last modified on 2020/01/21 20:41:53

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Basic information

Public title

The Duration of state effect of
Su-soku meditation on cognitive functions.

Acronym

The Duration of state effect of
Meditation.

Scientific Title

The Duration of state effect of
Su-soku meditation on cognitive functions.

Scientific Title:Acronym

The Duration of state effect of
Meditation.

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 on the cognitive functions.
To examine the duration of the effect of the single session meditation on the cognitive functions.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Experiment_1: The color-word matching Stroop task
Experiment_2: Operation span test

Key secondary outcomes

The Two-Dimensional Mood Scale
Quality of meditation
The 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
The trust scale
The epistemic curiosity scale


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

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

Exclusion criteria will be with history of Psychiatry and Neurology illness, pregnant, left-handed, meditation practitioner.

Target sample size

80


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 980-8575, Japan

TEL

022-717-7988

Email

ryuta@tohoku.ac.jp


Public contact

Name of contact person

1st name Noriki
Middle name
Last name Yamaya

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Functional Brain Imaging

Zip code

980-8575

Address

4-1 Seiryocho, Aobaku, Sendai 980-8575, Japan

TEL

022-717-7988

Homepage URL


Email

n.yamaya@med.tohoku.ac.jp


Sponsor or person

Institute

Institute of Development, Aging and Cancer (IDAC), Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Institute of Development, Aging and Cancer (IDAC), Tohoku University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee Tohoku University Graduate 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

東北大学加齢医学研究所(宮城県)
Institute of Development, Aging and Cancer, Tohoku University
(Miyagi Prefecture)


Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 14 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

Completed

Date of protocol fixation

2018 Year 11 Month 02 Day

Date of IRB

2018 Year 12 Month 21 Day

Anticipated trial start date

2019 Year 01 Month 01 Day

Last follow-up date

2019 Year 12 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

2018 Year 11 Month 14 Day

Last modified on

2020 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039772


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name