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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040263
Receipt No. R000045928
Scientific Title Changes of problem behaviors through recreational therapy:Effects of recreational programs held at monitoring zone of closed ward
Date of disclosure of the study information 2020/04/28
Last modified on 2020/12/07

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Basic information
Public title Changes of problem behaviors through recreational therapy:Effects of recreational programs held at monitoring zone of closed ward
Acronym Effects of recreational therapy at monitoring zone
Scientific Title Changes of problem behaviors through recreational therapy:Effects of recreational programs held at monitoring zone of closed ward
Scientific Title:Acronym Effects of recreational therapy at monitoring zone
Region
Japan

Condition
Condition Schizophrenia
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To improve the psychopathology and social function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rehabilitation Evaluation of Hall and Baker(REHAB)
Key secondary outcomes 1)Changes of patients'talk contents and facilal expressions,2)Brief Psychiatric Raing Scale(BPRS)

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Recreational therapy
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Long-term hospitalized patients for more than five years who have stayed at monitoring zone for more than one year
Key exclusion criteria Hospitalized patients for less than five years whose stay at monitoring zone for less than one year
Target sample size 3

Research contact person
Name of lead principal investigator
1st name Hidaka
Middle name
Last name Naomi
Organization Sawa Hospital
Division name Nursing Division
Zip code 561-0803
Address 1-9-1Siroyama,Toyonaka City,Oosaka,Japan,561-0803
TEL 06-8685-1211
Email nur@hokuto-kai.com

Public contact
Name of contact person
1st name Hidaka
Middle name
Last name Naomi
Organization Sawa Hospital
Division name Nursing Division
Zip code 561-0803
Address 1-9-1Siroyama,Toyonaka City,Oosaka,Japan,561-0803
TEL 06-8685-1211
Homepage URL
Email nur@hokuto-kai.com

Sponsor
Institute Sawa Hospital
Institute
Department

Funding Source
Organization Sawa Hospital
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 1-9-1Siroyama,Toyonaka City,Oosaka,Japan,561-0803
Tel 06-6865-1211
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 04 Month 28 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
2020 Year 01 Month 28 Day
Date of IRB
2020 Year 03 Month 30 Day
Anticipated trial start date
2020 Year 04 Month 28 Day
Last follow-up date
2020 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 28 Day
Last modified on
2020 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045928

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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