UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050082 |
|---|---|
| Receipt number | R000057052 |
| Scientific Title | Investigation of the Effect of Brief Meditation on Fatigue: A Nonrandomized Controlled Experiment |
| Date of disclosure of the study information | 2023/01/19 |
| Last modified on | 2024/01/22 08:45:00 |
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Basic information
Public title
Investigation of the Effect of Brief Meditation on Fatigue
Acronym
Investigation of the Effect of Brief Meditation on Fatigue
Scientific Title
Investigation of the Effect of Brief Meditation on Fatigue: A Nonrandomized Controlled Experiment
Scientific Title:Acronym
Investigation of the Effect of Brief Meditation on Fatigue
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To confirm the effect of meditation
2) To Assess the Feasibility of the Neurofeedback System Meditation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of Checklist Individual Strength Questionnaire(Before, 4 weeks, and 8 weeks after intervention)
Key secondary outcomes
The Japanese edition Fatigue Severity Scale
The Japanese version of the Pittsburgh Sleep Quality Index
The Japanese version of the Five Facet Mindfulness Questionnaire
The Japanese version of the Perth Emotion Regulation Competency Inventory
Motivation to meditate, difficulty in meditating, presence or absence of adverse events, number of days meditating during the intervention period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Meditation with a neurofeedback system (15 minutes a day for 8 weeks)
Interventions/Control_2
Meditation with a guidebook (15 minutes a day for 8 weeks)
Interventions/Control_3
Sham meditation with a guidebook (15 minutes a day for 8 weeks)
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy people
Age 20-40 years old
Inexperienced meditators
Feel fatigue from the past 2 weeks
Those who can give written consent to participate in the study
Key exclusion criteria
Persons with a history of or suffering from neuropsychiatric disorders
Persons who have taken supplements or medications related to anti-fatigue effects in the past 2 weeks
Persons who have experienced panic attacks or hyperventilation in the past
Persons who have experienced trauma in the past
Persons who are aware that they are prone to anxiety
Target sample size
93
Research contact person
Name of lead principal investigator
| 1st name | Ryuta |
| Middle name | |
| Last name | Kawashima |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Department of Functional Brain Imaging
Zip code
9808575
Address
4-1 Seiryo-machi, Aobaku, Sendai, Miyagi
TEL
022-717-7988
ryuta@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Noriki |
| Middle name | |
| Last name | Yamaya |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Department of Functional Brain Imaging
Zip code
9808575
Address
4-1 Seiryo-machi, Aobaku, Sendai, Miyagi
TEL
022-717-7988
Homepage URL
noriki.yamaya.s8@dc.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
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
| 2023 | Year | 01 | Month | 19 | 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
87
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | 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
| 2023 | Year | 01 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057052
