UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044407 |
|---|---|
| Receipt number | R000050722 |
| Scientific Title | The effects of trauma-informed care video training for psychiatric nurses: A Non-Randomized Controlled Trial Using a Mixed Research Approach |
| Date of disclosure of the study information | 2021/06/03 |
| Last modified on | 2021/12/03 00:10:22 |
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Basic information
Public title
The effects of trauma-informed care video training for psychiatric nurses: A Non-Randomized Controlled Trial Using a Mixed Research Approach
Acronym
The effects of trauma-informed care video training for psychiatric nurses: A Non-Randomized Controlled Trial Using a Mixed Research Approach (TIC-PN)
Scientific Title
The effects of trauma-informed care video training for psychiatric nurses: A Non-Randomized Controlled Trial Using a Mixed Research Approach
Scientific Title:Acronym
The effects of trauma-informed care video training for psychiatric nurses: A Non-Randomized Controlled Trial Using a Mixed Research Approach (TIC-PN)
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a newly developed trauma informed care video training for psychiatric nurses on nurses' attitudes and practices toward trauma informed care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Attitude Related trauma-Informed Care Scale 35 after intervention implementation
Key secondary outcomes
Nurses (post-intervention, and 3 months post-intervention):
Attitude Related trauma-Informed Care Scale 35 (3 months post-intervention)
Trauma Provider Survey
Japanese Burnout Scale
Psychological Safety
Kessler Psychological Distress Scale (K6)
Inpatients (1 month post-intervention):
VOICE
Japanese version of the Client Satisfaction Questionnaire 8-item version (CSQ-8)
Brief INSPIRE-J
Other:
Incident reports
Data on seclusion and restraint
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Behavior,custom | Other |
Interventions/Control_1
Intervention group:.
Within four weeks, view four trauma-informed care video trainings based on the principles of trauma-informed care.
Module 1) Description of Trauma Informed Care
Module 2) Description of Trauma Symptoms
Module 3) Case studies including trauma perspectives
Module 4) Practice of Trauma Informed Care
Interventions/Control_2
Control group: None
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Nurses and assistant nurses working in psychiatric wards
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Nishi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3364
d-nishi@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Kotake |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Psychiatric Nursing
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3522
Homepage URL
tic.kenkyu@gmail.com
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel
03-5841-0818
ethics@m.u-tokyo.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
吉祥寺病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 02 | Day |
Last modified on
| 2021 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050722
| 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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| Registered date | File name |
