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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038008
Receipt No. 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

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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
Email 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
Email tawa@nagahp.jp

Sponsor
Institute Naga Municipal Hospital
Medical Technology Department Rehabilitation Section
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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