UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030276 |
|---|---|
| Receipt number | 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 11:15:20 |
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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
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
Mieko.Omura@uon.edu.au
Sponsor or person
Institute
The University of Australia
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034577
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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