臨床研究等提出・公開システム

Date of registration	June. 13, 2023
Last modified on	June. 16, 2025
Trial ID	jRCT1030230132

Scientific Title	Development and validation of the educational program with people with mental disabilities to reduce seclusion and restraint in psychiatric hospitals
Public Title	Development and validation of the educational program with people with mental disabilities to reduce seclusion and restraint in psychiatric hospitals

Contact for Scientific Queries	Name	MIYAKE Michi
	Affiliation	National Institute of Mental Health, National Center of Neurology and Psychiatry
	Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo
	Telephone	+81-42-341-2711
	E-mail	miyakem@ncnp.go.jp
Contact for Public Queries	Name	MIYAKE Michi
	Affiliation	National Institute of Mental Health, National Center of Neurology and Psychiatry
	Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo
	Telephone	+81-42-341-2712
	E-mail	miyakem@ncnp.go.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		June. 01, 2023
Target sample size		300
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Nurses 1) Nurses working in psychiatric hospitals 2) Nurses working in inpatients wards Patients 1) Patients admitted to psychiatric hospitals 2) Patients being able to make their own decisions 3) Patients who are 20 years old or over
	Exclusion Criteria	Nurses 1) Nurses who are not working in inpatients wards 2) Nurses who are deemed inappropriate for the participation by the principal investigator Patients 1) Patients who have difficulty expressing their will for any reason, such as mental or physical symptoms 2) Patients who are deemed inappropriate for the participation by the principal investigator
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		mental illness
Intervention(s)		The training is delivered using a video developed with people with mental disabilities. The training video is approximately 25 minutes long and includes the importance of listening to people with mental disabilities, their lived experiences, and their hopes for medical professionals. After watching the video, 15 minutes of group work is provided to reflect on the content of the video.
Intervention(s) Keyword		Collaborating with people who have a mental disability, Training by Video
Primary Outcome(s)		Staff Attitude to Coercion Scale Essen Climate Evaluation Schema Emotional Labor Inventory for Nurses The nurses ethical behavior scale Client Satisfaction Questionnaire
Secondary Outcome(s)		Frequency and duration of the use of seclusion and restraint

Primary Sponsor	National Institute of Mental Health, National Center of Neurology and Psychiatry

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	National Center of Neurology and Psychiatry Ethics Committee
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Tokyo
Telephone	+81-42-341-2712-7828
E-Mail	crb-jimu@ncnp.go.jp
Approval Status	Approval
Date of approval	April. 07, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	June. 16, 2025	(this page)	Changes
2	June. 25, 2023	Detail	Changes
1	June. 13, 2023	Detail

List of change history