UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030333
Receipt number R000034437
Scientific Title Observational study about the effctiveness of expressing a positive event by writing on the occupational stress reactions of care workers.
Date of disclosure of the study information 2018/01/15
Last modified on 2017/12/10 14:10:54

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Basic information

Public title

Observational study about the effctiveness of expressing a positive event by writing on the occupational stress reactions of care workers.

Acronym

Effectweness of expressing a positive event by writing on the occupational stress reactions of care workers.

Scientific Title

Observational study about the effctiveness of expressing a positive event by writing on the occupational stress reactions of care workers.

Scientific Title:Acronym

Effectweness of expressing a positive event by writing on the occupational stress reactions of care workers.

Region

Japan


Condition

Condition

occupational stress reaction

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effectiveness of expressing a positive event by writing on the occupational stress reactions of care workers engaged in the care facility for social welfare for the aged.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

occupational stress reactions,depressed state and work engagement.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Care workers engaging in all 110 care facilities for social welfare for the aged in wakayama(2,680)
Care workers engaging in care facilities which participate in this study who give the informed consent to this study,who participate in study and who submit the guestimnaire.

Key exclusion criteria

Those whose guestionnaire is imcomplete in
many items.Those who do not agree the connection of the guestionnaire

Target sample size

320


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ikuharu Morioka

Organization

Wakayma Medical University

Division name

Graduate School of Health and Nursing Science

Zip code


Address

Mikazura 580, Wakayama

TEL

073-446-6700

Email

moriokai@wakayama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ikuharu Morioka

Organization

Wakayma Medical University

Division name

Graduate School of Health and Nursing Science

Zip code


Address

Mikazura 580, Wakayama

TEL

073-446-6700

Homepage URL


Email

moriokai@wakayama-med.ac.jp


Sponsor or person

Institute

Wakayma Medical University

Institute

Department

Personal name



Funding Source

Organization

Wakayma Medical University

Organization

Division

Category of Funding Organization

Self funding

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

2018 Year 01 Month 15 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

2018 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2019 Year 01 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Care workers has the possibity to have fatigue and lumbago bofore intervention fatigue and lumbago will be decreased after intervention


Management information

Registered date

2017 Year 12 Month 10 Day

Last modified on

2017 Year 12 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034437


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name