UMIN-CTR Clinical Trial

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

mental health

Classification by specialty

Nursing

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

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

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

08

Month

09

Day

URL releasing protocol

Publication of results

Published

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

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 related 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