UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007211
Receipt number R000008489
Scientific Title Study of the sense of self-growth in human service professionals
Date of disclosure of the study information 2012/02/02
Last modified on 2012/02/02 15:41:04

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Basic information

Public title

Study of the sense of self-growth in human service professionals

Acronym

Study of the sense of self-growth in human service professionals

Scientific Title

Study of the sense of self-growth in human service professionals

Scientific Title:Acronym

Study of the sense of self-growth in human service professionals

Region

Japan


Condition

Condition

Healthy adults (nurses)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The study examines the sense of self-growth and burnout in hospital nurses. Moreover, we investigate whether talking and sharing with others about events and experiences on nursing stimulates self-growth in them.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sense of self-growth :Japanese Version of the Posttraumatic Growth Inventory (PTGI)
Burnout: Copenhagen Burnout Inventory (CBI)
Job characteristics of nurse : Emotional Labor Inventory for Nurses (ELIN)
Personality characteristics: 15-item Hardiness Scale
Stressor and social support:Brief Job Stress Questionnaire, Total experienced stress score from life event

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom Maneuver

Interventions/Control_1

For the intervention group, both questionnaire surveys and individual interviews with a clinical psychologist are conducted and carried out for one year, three times every six months. The individual interviews is a semi-structured interview, and subjects could freely reply to questions regarding their reasons of becoming human service professionals, difficulty and significance of their work, handling of their emotion, and changes involved in human service.

Interventions/Control_2

The control group answers only questionnaire surveys for one year, three times every six months. The investigation items of the questionnaires for the control group are same as that of the intervention group.

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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

This includes hospital nurses who understood the contents of the description of this study and gave written informed consent, agreeing to cooperate during the investigations.

Key exclusion criteria

This includes hospital nurses who did not give written informed consent.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoko OKUNO

Organization

Kinki University Faculty of Medicine

Division name

Department of Environmental Medicine and Behavioural Science

Zip code


Address

377-2, Ohno-higashi, Osakasayama, Osaka, 589-8511, Japan

TEL

072-366-0221

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kinki University Faculty of Medicine

Division name

Department of Environmental Medicine and Behavioural Science

Zip code


Address


TEL

072-366-0221

Homepage URL


Email



Sponsor or person

Institute

Kinki University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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

2012 Year 02 Month 02 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

No longer recruiting

Date of protocol fixation

2010 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 09 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

2012 Year 02 Month 02 Day

Last modified on

2012 Year 02 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008489


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name