UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026012 |
|---|---|
| Receipt number | 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 | 2020/01/21 20:44:47 |
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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)
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
m14205601@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
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
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
| 2017 | Year | 01 | Month | 23 | Day |
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
| 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=R000029903
