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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030276
Receipt No. R000034577
Scientific Title Evaluating the impact of an assertiveness communication training program for Japanese nursing students using the Theory of Planned Behaviour
Date of disclosure of the study information 2017/12/05
Last modified on 2018/12/06

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Basic information
Public title Evaluating the impact of an assertiveness communication training program for Japanese nursing students using the Theory of Planned Behaviour
Acronym The impact of an assertiveness communication training program for Japanese nursing students
Scientific Title Evaluating the impact of an assertiveness communication training program for Japanese nursing students using the Theory of Planned Behaviour
Scientific Title:Acronym The impact of an assertiveness communication training program for Japanese nursing students
Region
Japan

Condition
Condition Nursing students
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the impact of an assertiveness communication training program for Japanese nursing students
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Behaviour intention to communicate assertively to health professionals when concerned about patients
Key secondary outcomes The level of assertiveness

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 A 90-minute assertiveness communication workshop
Interventions/Control_2 No intervention
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 2nd, 3rd, 4th year nursing students in Japan
Key exclusion criteria 1st year nursing students
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tracy Levett-Jones
Organization The University of Newcastle
Division name School of Nursing and Midwifery
Zip code
Address University Drive, Callaghan, NSW 2308 Australia
TEL +61-400940438
Email tracy.levett-jones@uts.edu.au

Public contact
Name of contact person
1st name
Middle name
Last name Mieko Omura
Organization The University of Newcastle
Division name School of Nusing and Midwefery
Zip code
Address University Drive, Callaghan, NSW 2308 Australia
TEL 08029474766
Homepage URL
Email Mieko.Omura@uon.edu.au

Sponsor
Institute The University of Australia
Institute
Department

Funding Source
Organization The University of Newcastle
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Australia

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 H-2017-0365
Org. issuing International ID_1 The University of Newcastle, Human Research Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 山口大学医学部保健学科(山口県)
岩国医療センター附属岩国看護学校(山口県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 05 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
A total of 123 out of 150 nursing students completed the surveys. Following the assertiveness communication training program, a higher percentage of students from the intervention group demonstrated the intention to speak up. The intervention group also displayed higher levels of assertiveness, although the results were not statistically significant.
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
2017 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 06 Day
Last follow-up date
2018 Year 01 Month 31 Day
Date of closure to data entry
2018 Year 02 Month 28 Day
Date trial data considered complete
2018 Year 04 Month 30 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 05 Day
Last modified on
2018 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034577

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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