UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049984 |
|---|---|
| Receipt number | R000056910 |
| Scientific Title | A Psychosomatic Study of the Impact of Short-Term Mindfulness Meditation on Chronic Pain |
| Date of disclosure of the study information | 2023/01/07 |
| Last modified on | 2023/01/07 08:35:48 |
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Basic information
Public title
A Psychosomatic Study of the Impact of Short-Term Mindfulness Meditation on Chronic Pain
Acronym
A Psychosomatic Study of the Impact of Short-Term Mindfulness Meditation on Chronic Pain
Scientific Title
A Psychosomatic Study of the Impact of Short-Term Mindfulness Meditation on Chronic Pain
Scientific Title:Acronym
A Psychosomatic Study of the Impact of Short-Term Mindfulness Meditation on Chronic Pain
Region
| Japan |
Condition
Condition
Chronic Pain
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A 2-week mindfulness intervention for chronic pain patients will be conducted to determine the effects on pain thresholds and psychological measures.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pressure pain threshold
Key secondary outcomes
Psychological assessment, pain related cognition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Mindfulness
Interventions/Control_2
Waiting
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) Age 20 years or older at the time consent is obtained
(2) Meet all of the diagnostic criteria for chronic pain.
(3) Persons who have been fully informed about their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study.
Key exclusion criteria
Those whose main illness is mental illness
Those with a diagnosis of diabetes mellitus
Patients with arrhythmia
Persons with cognitive impairment
Persons with pain in the forearm
Persons who are proficient in Mindfulness-Based Stress Reduction (MBSR)
Other subjects deemed inappropriate as research subjects by the principal investigator.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Kento |
| Middle name | |
| Last name | Ueda |
Organization
Kansai Medical University
Division name
Graduate School of Medicine, Medical Sciences, Psychosomatic Medicine
Zip code
573-1010
Address
2-5-1-505 Shinmachi, Hirakata, Osaka
TEL
072-804-0101
u.k.1994.0102@gmail.com
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Ueda |
Organization
Kansai Medical University
Division name
Graduate School of Medicine, Medical Sciences, Psychosomatic Medicine
Zip code
072-804-0101
Address
2-5-1-505 Shinmachi, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
u.k.1994.0102@gmail.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
No
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
Kansai Medical University Hospital Research Ethics Review Committee
Address
2-3-1 Shinmachi, Hirakata, Osaka
Tel
072-804-0101
u.k.1994.0102@gmail.com
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 | 07 | 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
45
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
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2023 | 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 | 07 | Day |
Last modified on
| 2023 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056910
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
