UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028580 |
|---|---|
| Receipt number | 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 14:02:18 |
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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
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
atatei@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Health Care and Nursing
Clinical trial to be implemented with Grant-in-Aid for Scientific Research
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032704
