UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050722