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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044407
Receipt No. 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 2021/06/02

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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

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
Email 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
Email tic.kenkyu@gmail.com

Sponsor
Institute The University of Tokyo
Institute
Department

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
Email 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
2021 Year 09 Month 22 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 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050722

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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