UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051536 |
|---|---|
| Receipt number | R000058780 |
| Scientific Title | Effectiveness of Mindfulness-Based Resilience Promotion Programs |
| Date of disclosure of the study information | 2023/07/06 |
| Last modified on | 2023/07/06 10:31:52 |
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Basic information
Public title
Effectiveness of Mindfulness-Based Resilience Promotion Programs
Acronym
Effectiveness of Mindfulness-Based Resilience Promotion Programs
Scientific Title
Effectiveness of Mindfulness-Based Resilience Promotion Programs
Scientific Title:Acronym
Effectiveness of Mindfulness-Based Resilience Promotion Programs
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study was to evaluate the effectiveness of a resilience promotion programme using mindfulness breathing techniques with students in late adolescence, using subjective and objective data to assess the effectiveness of the programme.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measures are skin potential and heart rate, and fluctuations in skin potential and heart rate due to stress loading are assessed. Skin potential is measured using Thought Technology's "ProComp Vital Monitor FlexComp". Heart rate is measured using "myBeat" by UNION TOOL.
Three evaluation periods were used. Specifically, immediately before the intervention (T0), immediately after the 4-week intervention (T1) and 4 weeks after the intervention (T2).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver | Other |
Interventions/Control_1
The intervention group will watch a video (created by the researchers) about low-intensity mindfulness at home. In addition, they will practice low-intensity mindfulness (breathing exercises for five minutes at a time) for four weeks.
Interventions/Control_2
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
| 22 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who are able to give informed consent.
Able to understand Japanese and communicate linguistically well, as psychoeducation is an important element of the programme.
Key exclusion criteria
Those who practice mindfulness or mindfulness-like yoga, meditation or breathing exercises on a daily basis.
Those who are currently undergoing cognitive behavioural therapy.
Those at significant risk of postpartum depression, dementia, intellectual disability, self-harm or other harm.
Those taking multiple antipsychotic medications (chlorpromazine equivalent 600 mg/day or more).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Ishida |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Nursing Faculty of Nursing
Zip code
7010193
Address
288,Matsushima,Kurashiki Okayama
TEL
0864621111
m-ishida@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Ishida |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Nursing Faculty of Nursing
Zip code
7010193
Address
288,Matsushima,Kurashiki Okayama
TEL
0864621111
Homepage URL
m-ishida@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki University of Medical Welfare
Address
288,Matsushima,Kurashiki Okayama
Tel
0864621111
m-ishida@mw.kawasaki-m.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 | 07 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | 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 | 07 | Month | 06 | Day |
Last modified on
| 2023 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058780
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
