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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028580
Receipt No. R000032704
Scientific Title The development of the Mindfulness Assertion program for nurses' mental health
Date of disclosure of the study information 2017/08/09
Last modified on 2017/08/08

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Basic information
Public title The development of the Mindfulness Assertion program for nurses' mental health
Acronym The development of the Mindfulness Assertion program for nurses
Scientific Title The development of the Mindfulness Assertion program for nurses' mental health
Scientific Title:Acronym The development of the Mindfulness Assertion program for nurses
Region
Japan

Condition
Condition mental health
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to develop and conduct a program combining mindfulness and assertion training and to evaluate its effects on the mental health of nurses.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes mental health (before the program, immediately after the program, and 2 months after the program(follow-up)
Key secondary outcomes Mood States, Burnout, Work Engagement, Occupational Stressor (before the program, immediately after the program, and 2 months after the program(follow-up)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1
contents of intervention: 12-week mindfulness and assertion program for Japanese nurses. The program involved six 3-hour sessions (every other week).
intervention period: 12weeks
In the program, participants will first experience mindfulness, continue practicing mindfulness in their daily lives, and learn ways to be more assertive.
Interventions/Control_2 the control group
For nurses in the control group, only questionnaire survey is conducted and no intervention is done. Nurses assigned to the control group participate in the same program after the survey.

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
21 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Nurses who work for the general hospital targeted
Key exclusion criteria Nurses who are under treatment and do not have permission to participate in the program from their doctor

Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayami Tateishi
Organization Juntendo University
Division name Faculty of Health Care and Nursing, Graduate School of Health Care and Nursing
Zip code
Address Takasu 2-1-1, Urayasu,Chiba 279-0023,Japan
TEL 047-355-3111
Email atatei@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayami Tateishi
Organization Juntendo University
Division name Faculty of Health Care and Nursing, Graduate School of Health Care and Nursing
Zip code
Address Takasu 2-1-1, Urayasu,Chiba 279-0023,Japan
TEL 047-355-3111
Homepage URL
Email atatei@juntendo.ac.jp

Sponsor
Institute Juntendo University Faculty of Health Care and Nursing
Clinical trial to be implemented with Grant-in-Aid for Scientific Research
Institute
Department

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
Address
Tel
Email

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
2017 Year 08 Month 09 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We created the program for nurses (six sessions and one follow-up session) and conducted it with nine participants working at a general hospital in the Kanto region. We conducted the same questionnaire survey at three time points (before the program, immediately after the program, and after the follow-up session) and analyzed data for seven nurses. Scores on the mental health scale (K6) and the vigor (UWES) scale differed across the three time points, with both scores improving during the program. Participants mentioned stabilization of feelings and compassion for others in their free-writing. These results suggest that the program will be useful for nurses' mental health.
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 Main results already published
Date of protocol fixation
2014 Year 09 Month 18 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 08 Day
Last modified on
2017 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032704

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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