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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026012
Receipt No. R000029903
Scientific Title Immediate effect of Breath counting meditation in Working Memory and its optimal time. -functional near infrared spectroscopy (fNIRS) study-
Date of disclosure of the study information 2017/02/06
Last modified on 2017/08/08

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Basic information
Public title Immediate effect of Breath counting meditation in Working Memory and its optimal time.
-functional near infrared spectroscopy (fNIRS) study-
Acronym The effect of Breath counting meditation
Scientific Title Immediate effect of Breath counting meditation in Working Memory and its optimal time.
-functional near infrared spectroscopy (fNIRS) study-
Scientific Title:Acronym The effect of Breath counting meditation
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1.To examine the effect of Breath counting meditation in working memory.
2.To examine the optimal time when doing Breath counting meditation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Japanese version reading span test,Letter stroop test(Before and after intervention)
Key secondary outcomes Changes in oxygenated hemoglobin concentration (During intervention)

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 not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Breath counting meditation
Perform 15 minutes once
Interventions/Control_2 Listen to the audio files
Perform 15 minutes once
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Healthy college student

Key exclusion criteria 1.Subjects who withdrew consent on the way in this study.
2.Subjects who have previous or present serious disease such as mental and physical diseases.
3.Subjects with meditation experience.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fusae Tozato
Organization Gunma University Graduate School
Division name Department of Rehabilitation, Graduate School of Health Sciences
Zip code
Address 3-39-22 shouwa-machi, Maebashi-shi, Gunma 371-8514, Japan
TEL 027-220-8955(ext.8955)
Email fusae@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriki Yamaya
Organization Gunma University
Division name School of Medicine Department of Health Sciences
Zip code
Address 3-39-22 shouwa-machi, Maebashi-shi, Gunma 371-8514, Japan
TEL 027-220-8955
Homepage URL
Email m14205601@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization None
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 群馬大学医学部保健学科(群馬県)
Gunma University School of Medicine Department of Health Sciences (Gunma)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 06 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
2017 Year 01 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 20 Day
Last follow-up date
2017 Year 06 Month 01 Day
Date of closure to data entry
2017 Year 06 Month 01 Day
Date trial data considered complete
2017 Year 06 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 06 Day
Last modified on
2017 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029903

Research Plan
Registered date File name
2017/08/08 計画書A_UMIN.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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