UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001008 |
|---|---|
| Receipt number | R000001214 |
| Scientific Title | Discovering the psychological care needs of patients hospitalized with physical disorders and the care provided by nurses. |
| Date of disclosure of the study information | 2008/02/01 |
| Last modified on | 2008/08/05 15:44:39 |
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Basic information
Public title
Discovering the psychological care needs of patients hospitalized with physical disorders and the care provided by nurses.
Acronym
Patients' psychological care needs and actual nursing practice
Scientific Title
Discovering the psychological care needs of patients hospitalized with physical disorders and the care provided by nurses.
Scientific Title:Acronym
Patients' psychological care needs and actual nursing practice
Region
| Japan |
Condition
Condition
All hospitalized patients, except pediatrics and psuchiatry
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Cardiology | Pneumology | Endocrinology and Metabolism |
| Hematology and clinical oncology | Nephrology | Neurology |
| Clinical immunology | Psychosomatic Internal Medicine | Infectious disease |
| Geriatrics | Surgery in general | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Vascular surgery | Chest surgery |
| Endocrine surgery | Breast surgery | Obstetrics and Gynecology |
| Ophthalmology | Dermatology | Oto-rhino-laryngology |
| Orthopedics | Urology | Radiology |
| Anesthesiology | Oral surgery | Neurosurgery |
| Cardiovascular surgery | Plastic surgery | Aesthetic surgery |
| Laboratory medicine | Operative medicine | Emergency medicine |
| Blood transfusion | Intensive care medicine | Rehabilitation medicine |
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1)To asess the mental condition and the needs for psychological support and nursing care among the hospitalized patients.
2)To investigate the actual condition of nurse's assesment about the patient's mental condition and nurse's actual psychological care for patients.
Basic objectives2
Others
Basic objectives -Others
To ssess by comparison the needs and actual condition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese Version Hospital Anxiety and Depression Scale
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 and Female
Key inclusion criteria
All the hospitalized patients and nurses with consent
Key exclusion criteria
Those reognized as insuitable by head nurses
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoka Nozue |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
Address
35 Shinanomachi Shinjuku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Keio University Faculty of Nursing and Medical Care
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2008 | Year | 02 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross-section
Management information
Registered date
| 2008 | Year | 02 | Month | 01 | Day |
Last modified on
| 2008 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001214
