UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022378
Receipt number R000025793
Scientific Title Brief Assertive Training for Nurses in the Workplace: A Preliminary Single-Group Study
Date of disclosure of the study information 2016/05/23
Last modified on 2017/11/13 11:48:31

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Basic information

Public title

Brief Assertive Training for Nurses in the Workplace: A Preliminary Single-Group Study

Acronym

Brief Assertive Training for Nurses in the Workplace

Scientific Title

Brief Assertive Training for Nurses in the Workplace: A Preliminary Single-Group Study

Scientific Title:Acronym

Brief Assertive Training for Nurses in the Workplace

Region

Japan


Condition

Condition

Nurses

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of brief assertiveness training for nurse through single group design without control group.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Japanese Rathus assertiveness schedule: J-RAS

Assessment points: Pre-intervention, post-intervention (1-month), 3-month follow-up, 6-month follow-up

Key secondary outcomes

- Fear of Negative Evaluation: FNE
- The Brief Job Stress Questionnaire

Exploratory outcome:
- Relation Communication Control Cording System: RCCCS

Same assessment schedule as primary outcome


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Assertive training (90-mins program, total 2 times with 1-month interval)

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Nurses
2. Obtaining written informed consent

Key exclusion criteria

1. Unstable physical condition (difficult to participate in the group training)
2. Participant who does not have adequate level of educational and linguistic ability.
3. Participant who were judged to be unsuitable for the study by the study investigator.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoki Yoshinaga

Organization

University of Miyazaki

Division name

Organization for Promotion of Tenure Track

Zip code


Address

5200 Kihara, Kiyotake, Miyazaki City, Miyazaki 889-1692, Japan.

TEL

0985-85-9784

Email

naoki-y@med.miyazaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Youhei Nakamura

Organization

University of Miyazaki

Division name

Graduate School of Nursing

Zip code


Address

5200 Kihara, Kiyotake, Miyazaki City, Miyazaki 889-1692, Japan.

TEL

0985-85-9784

Homepage URL


Email

youhei_nakamura@med.miyazaki-u.ac.jp


Sponsor or person

Institute

University of Miyazaki

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency (JST)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


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

宮崎大学医学部附属病院(宮崎県)University of Miyazaki Hospital (Miyazaki)、医療法人如月会若草病院(宮崎県)Wakakusa Hospital (Miyazaki)、医療法人同仁会谷口病院(宮崎県)Taniguchi Hospital (Miyazaki)


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 23 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/28744987

Number of participants that the trial has enrolled


Results

A total of 33 nurses received the training, and the mean RAS score improved from -14.2 (SD=16.5) pre-training to -10.5 (SD=18.0) post-training (p<0.05). These improvements were maintained until the 6-month follow-up. The pre-post effect size of 0.22 (indicating small effect) was larger than the effect sizes ranging from -0.56 to 0.17 (no effect) reported in previous studies that used brief training. Modified brief assertiveness training seems feasible and may achieve long-term favourable outcomes in improving assertiveness among nurses.

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

Completed

Date of protocol fixation

2016 Year 04 Month 25 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 24 Day

Last follow-up date

2016 Year 12 Month 31 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete

2017 Year 03 Month 31 Day

Date analysis concluded

2017 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 05 Month 20 Day

Last modified on

2017 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025793


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name