UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034076 |
|---|---|
| Receipt number | 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 14:12:21 |
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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
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
nur@hokuto-kai.com
Sponsor or person
Institute
Social medicine corporation Hokuto-kai
Institute
Department
Personal name
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)
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038843
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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