UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057339 |
|---|---|
| Receipt number | R000065539 |
| Scientific Title | The effect examination of the group of psychiatry young person nurses cognitive-behavioral therapy program to reduce negative emotions after the verbal violence damage: Mixed methods research |
| Date of disclosure of the study information | 2025/03/19 |
| Last modified on | 2025/03/19 15:22:20 |
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Basic information
Public title
Effect examination of the group of psychiatry young person nurses cognitive-behavioral therapy program to reduce negative emotions who received
verbal violence
Acronym
Effect on young nurse examination of the negative emotions reduction program of the psychiatry which received verbal violence
Scientific Title
The effect examination of the group of psychiatry young person nurses cognitive-behavioral therapy program to reduce negative emotions after the verbal
violence damage: Mixed methods research
Scientific Title:Acronym
Effect on psychiatry young person nurse examination after the verbal violence damage of the negative emotions reduction program
Region
| Japan |
Condition
Condition
Negative emotions of the psychiatry young person nurse after the verbal violence damage
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of a group cognitive behavioral therapy program to reduce negative emotions in junior psychiatric nurses after being
victims of verbal violence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study examines the effectiveness of a group cognitive behavioral therapy program to reduce negative emotions following verbal violence using the
abbreviated version of the Japanese Profile of Mood States 2nd Edition.
Key secondary outcomes
The secondary effects of a group cognitive behavioral therapy program to reduce negative emotions after verbal violence will be examined using the
Negative Emotional Suppression Tendency Scale and K6.
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
| Other |
Interventions/Control_1
The intervention will be conducted online in one session from 10:00 to 16:00. The format will include lectures, exercises, individual work, and group work, and will be conducted by an interventionist with approximately 2 to 7 people per session.
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Nurses in their 20s with 1 to 3 years of nursing and psychiatric experience who have experienced or currently experience negative emotions due to verbal violence from patients
Key exclusion criteria
Nurses with a cutoff score of 24 or higher on the Impact of Event Scale-Revised (IES-R)
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Yoshie |
| Middle name | |
| Last name | Okada |
Organization
International University of Health and Welfare
Division name
School of Nursing at Narita
Zip code
286-8686
Address
4-3 Kotsunomori, Narita City, Chiba Prefecture
TEL
0476-20-7723
yoshiok@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Shigeta |
Organization
International University of Health and Welfare Graduate School
Division name
Graduate School of Medical and Welfare Studies
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo
TEL
03-5574-3900
Homepage URL
stargazewith29@gmail.com
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
others
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
International University of Health and Welfare Ethics Committee
Address
4-1-26 Akasaka, Minato-ku, Tokyo
Tel
03-5574-3900
rinri-tky@iuhw.ac.jp
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
| 2025 | Year | 03 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065539
