UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038008 |
|---|---|
| Receipt number | R000043237 |
| Scientific Title | Study on Mindfulness Program for Hospital Staff |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2019/09/13 13:16:47 |
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Basic information
Public title
Study on Mindfulness Program for Hospital Staff
Acronym
Study on Mindfulness Program for Hospital Staff
Scientific Title
Study on Mindfulness Program for Hospital Staff
Scientific Title:Acronym
Study on Mindfulness Program for Hospital Staff
Region
| Japan |
Condition
Condition
Psychological stress and resilience of hospital staff
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether a mindfulness program for Naga hospital staff has effects on burnout prevention,stress reduction,and QOL improvement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Perceived Stress Scale(PSS)
Key secondary outcomes
･State-Trait Anxiety Inventory-Form JYZ(STAI)
･Profile of Mood States(POMS)
･WHO QOL 26
･Tokyo University Egogram New Ver.2
･Five Facet Mindfulness Questionnaire(FFMQ)
･Connor-Davidson Resilience Scale(CD-RISC)
･Subjective Well-Being Scale
･Self-Compassion Scale(SCS)
･Maslach Burnout Inventory-Human Services Survey(MBI-HSS)
･The Brief Job Stress Questionnaire
･Mindfulness Familiarity Questionnire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Mindfulness Program for Hospital staff
Mindfulness-based program,40-minutes workshop once a week for 10weeks
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
･Medical staff such as doctors,nurses,clinical psychologists,administrative staff working at Naga Hospital.
･Those who will be able to articipate/commit in the whole program.
･Those who can indicate their consent in documents.
Key exclusion criteria
･Those who has a serious physical illness.
･Those who are decided to be difficult to participate in research by research team.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Tawa |
Organization
Naga Municipal Hospital
Division name
Medical Technology Department Rehabilitation Section
Zip code
649-6414
Address
1282,Uchita,Kinokawa city,Wakayama prefecture,Japan
TEL
0736-77-2019
tawa@nagahp.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Tawa |
Organization
Naga Municipal Hospital
Division name
Medical Technology Department Rehabilitation Section
Zip code
648-6414
Address
1282,Uchita,Kinokawa city,Wakayama prefecture,Japan
TEL
0736-77-2019
Homepage URL
tawa@nagahp.jp
Sponsor or person
Institute
Naga Municipal Hospital
Medical Technology Department Rehabilitation Section
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
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Naga Municipal Hospital
Address
1282,Uchita,Kinokawa city,Wakayama prefecture,Japan
Tel
0736-77-2019
tawa@nagahp.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
公立那賀病院（和歌山県）
（Naga Municipal Hospital,Wakayama Japan)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 01 | 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
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 13 | Day |
Last modified on
| 2019 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043237
| 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 |
