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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034076
Receipt No. R000038843
Scientific Title Segregation in psychiatric emergency wards involvement using presentation to restrained patients ~ Effective for reducing anxiety and dissatisfaction with behavior restriction?
Date of disclosure of the study information 2020/03/31
Last modified on 2020/09/11

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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/ctr_e/ctr_view.cgi?recptno=R000038843

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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