UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056413 |
|---|---|
| Receipt number | R000064454 |
| Scientific Title | Investigating the effect of meditation intervention frequency |
| Date of disclosure of the study information | 2024/12/10 |
| Last modified on | 2024/12/10 15:23:57 |
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Basic information
Public title
Investigating the effect of meditation intervention frequency
Acronym
Investigating the effect of meditation intervention frequency
Scientific Title
Investigating the effect of meditation intervention frequency
Scientific Title:Acronym
Investigating the effect of meditation intervention frequency
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the intervention frequency effects of meditation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mental health status (DASS-21)
Key secondary outcomes
Mindfulness traits (FFMQ)
Emotional regulatory capacity (PERCI)
Emotional state (PANAS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Meditation (high frequency)
Interventions/Control_2
Meditation (low frequency)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Right-handed
Inexperienced meditator
No previous experience of hyperventilation or panic attacks
Key exclusion criteria
(1) Those with a history of neurological or mental illness.
(2) Those with visual or hearing impairments that prevent them from performing tasks.
(3) Those with a smoking habit.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Tsuchiya |
Organization
Nagano University of Health and Medicine
Division name
Department of Rehabilitation
Zip code
381-2227
Address
11-1 Imaihara-Kawanakajima, Nagano, Nagano
TEL
026-283-6111
tsuchiya.kenji@shitoku.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Tsuchiya |
Organization
Nagano University of Health and Medicine
Division name
Department of Rehabilitation
Zip code
381-2227
Address
11-1 Imaihara-Kawanakajima, Nagano, Nagano
TEL
026-283-6111
Homepage URL
tsuchiya.kenji@shitoku.ac.jp
Sponsor or person
Institute
Nagano University of Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagano University of Health and Medicine
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
Institutional Review Board of Nagano University of Health and Medicine
Address
11-1 Imaihara-Kawanakajima, Nagano, Nagano
Tel
026-283-6111
Non
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
| 2024 | Year | 12 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2024 | Year | 12 | Month | 10 | Day |
Last modified on
| 2024 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064454
