UMIN-CTR Clinical Trial

Basic information
Public title	Segregation in psychiatric emergency wards involvement using presentation to restrained patients ~ Effective for reducing anxiety and dissatisfaction with behavior restriction?
Acronym	Segregation in psychiatric emergency wards involvement using presentation to restrained patients ~ Effective for reducing anxiety and dissatisfaction with behavior restriction?
Scientific Title	Segregation in psychiatric emergency wards involvement using presentation to restrained patients ~ Effective for reducing anxiety and dissatisfaction with behavior restriction?
Scientific Title:Acronym	Segregation in psychiatric emergency wards involvement using presentation to restrained patients ~ Effective for reducing anxiety and dissatisfaction with behavior restriction?
Region	Japan

Condition
Condition	Among ICD-10,mainly F1-F4
Classification by specialty	Neurology Psychosomatic Internal Medicine Psychiatry Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate whether the involvement using the presentation to quarantine / restrained patients is effective in alleviating patient anxiety and dissatisfaction. Investigate the attitudes of the staff who used the presentation. We also verify whether it is effective for reducing the number of days to limit action.
Basic objectives2	Others
Basic objectives -Others	Simple summary cross tabulation questionnaire
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	For the period of 3 months, use the presentation for subjects who have performed quarantine / restraint. It is possible to alleviate any anxiety or dissatisfaction of patients due to behavioral restrictions.
Key secondary outcomes	If we can encourage the understanding of the necessity of behavior restriction by presentation, it will lead to the minimization of behavioral restriction

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Indication period of isolation / restraint
Interventions/Control_2	If necessary
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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Inpatient who underwent isolation / detention under ICD-10 mental health care instructions, one week after the cancellation. Mainly F1 - F4
Key exclusion criteria	Those who have difficulty understanding the contents of the presentation and question paper in F0, F7 - F9. (People with dementia or intellectual disabilities) Underage. Patient undergoing quarantine / restraint for physical management purposes. Person who quarantines by hope. Those who do not satisfy death / transference / target period. When there is a refusal declaration from the substitute person and the target person.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name matuura Middle name Last name teruaki
Organization	Social medicine corporation Hokuto-kai Hokuto Clinic hospital
Division name	Nursing department
Zip code	551-0001
Address	1-18-7, Sangenyanishi, Taisho-ku Osaka-shi, Osaka, 551-0001, Japan
TEL	06-6554-1399
Email	nur@hokuto-kai.com

Public contact
Name of contact person	1st name matuura Middle name Last name teruaki
Organization	Social medicine corporation Hokuto-kai Hokuto Clinic hospital
Division name	Nursing department
Zip code	551-0001
Address	1-18-7, Sangenyanishi, Taisho-ku Osaka-shi, Osaka
TEL	06-6554-1399
Homepage URL
Email	nur@hokuto-kai.com

Sponsor
Institute	Social medicine corporation Hokuto-kai
Institute
Department

Funding Source
Organization	Social medicine corporation hokuto-kai
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research ethics committee, Social medical corporation Hokutokai
Address	1-9-1 Shiroyama-cho, Toyonaka City, Osaka
Tel	06-6865-1211(7610)
Email	clin-res@hokuto-kai.com

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	2020 Year 03 Month 31 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	Completed
Date of protocol fixation	2018 Year 09 Month 01 Day
Date of IRB	2018 Year 08 Month 30 Day
Anticipated trial start date	2018 Year 08 Month 30 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 09 Month 10 Day
Last modified on	2020 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038843