UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038233 |
|---|---|
| Receipt number | R000043580 |
| Scientific Title | Efficacy of mindfulness meditation for the inpatients in a long-term closed psychiatric hospital ward |
| Date of disclosure of the study information | 2019/10/08 |
| Last modified on | 2021/03/26 14:19:53 |
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Basic information
Public title
Efficacy of mindfulness meditation for the inpatients in a long-term closed psychiatric hospital ward
Acronym
Efficacy of mindfulness meditation for the inpatients in a long-term closed psychiatric hospital ward
Scientific Title
Efficacy of mindfulness meditation for the inpatients in a long-term closed psychiatric hospital ward
Scientific Title:Acronym
Efficacy of mindfulness meditation for the inpatients in a long-term closed psychiatric hospital ward
Region
| Japan |
Condition
Condition
psychiatric disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the efficacy of mindfulness meditation for the inpatients in a long-term closed psychiatric ward.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
STAI
Key secondary outcomes
Original questionnaire survey
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
2 week mindfulness meditation program
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Those who
1)are complaining irritability and/or anxiety that are also observed by the nursing staff
2)can understand and answer STAI and survey
3)consent to the protocol
4)are allowed to participate by the attending physicians
Key exclusion criteria
Those who are not satisfied with any of the conditions above.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shiho |
| Middle name | |
| Last name | Yamawaki |
Organization
Social medical corporation Sawa Hospital
Division name
nursing department
Zip code
5610803
Address
1-9-1, Shiroyamatown, Toyonakacity, Osaka
TEL
0668651211
nur@hokuto-kai.com
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Yamawaki |
Organization
Social medical corporation Sawa Hospital
Division name
nursing department
Zip code
5610803
Address
1-9-1, Shiroyamatown, Toyonakacity, Osaka
TEL
0668651211
Homepage URL
nur@hokuto-kai.com
Sponsor or person
Institute
Social medical corporation Sawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Social medical corporation 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
1-9-1, Shiroyamatown, Toyonakacity, Osaka
Tel
06-6865-1211(ext.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
| 2019 | Year | 10 | Month | 08 | 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
| 2019 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 08 | Day |
Last modified on
| 2021 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043580
