UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032932 |
|---|---|
| Receipt number | R000037540 |
| Scientific Title | Implementation of delirium care after an operation in a gastrointestinal surgery ward |
| Date of disclosure of the study information | 2018/06/08 |
| Last modified on | 2021/12/17 16:32:07 |
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Basic information
Public title
Implementation of delirium care after an operation in a gastrointestinal surgery ward
Acronym
Implementation of delirium care after an operation in a gastrointestinal surgery ward
Scientific Title
Implementation of delirium care after an operation in a gastrointestinal surgery ward
Scientific Title:Acronym
Implementation of delirium care after an operation in a gastrointestinal surgery ward
Region
| Japan |
Condition
Condition
Delirium
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A nurse acquires knowledge of delirium as a result of the education to a nurse, and a period of the number of patients who develop delirium at the same time and delirium diminishes in whether I was able to care now, and it was possible to stop fall falls by delirium or I make it clear.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mentioning for a questionnaire survey is unnecessary.
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
1) Nurse manager and a nursing study member take a delirium care course and learn use method for delirium assessment seat introduction.
2) I question about the degree of the knowledge and the implementation situation of the care of the delirium care before a delirium care study meeting and investigate about the degree of the knowledge and correspondence to delirium of our ward nurse.
3) a study meeting is performed about delirium care and use method of an assessment seat targeted for the nurse.
4) the degree of the knowledge and the implementation situation of the care of the delirium care are measured using just after the study meeting end and the same one as a questionnaire which was performed before a study meeting 6 months later.
5) a questionnaire result is analyzed using rank sum test with a sign of Wilcoxon.
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
Male and Female
Key inclusion criteria
The patient hospitalized at the general anesthesia destinations of a gullet and a liver by gastrointestinal surgery
Key exclusion criteria
Local anesthesia is removed
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Harada |
Organization
Kochi Medical School Hospital
Division name
Nursing Department
Zip code
783-8505
Address
Okochokohasu, Nankoku-shi, Kochi.
TEL
088-880-2459
jm-c-harada@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Harada |
| Middle name | |
| Last name | Chie |
Organization
Kochi Medical School Hospital
Division name
Nursing Department
Zip code
7883-8505
Address
Okochokohasu, Nankoku-shi, Kochi.
TEL
088-880-2459
Homepage URL
jm-c-harada@kochi-u.ac.jp
Sponsor or person
Institute
Kochi Unversity
Institute
Department
Personal name
Funding Source
Organization
Kochi Unversity
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
Kochi Medical School Hospital
Address
Okochokohasu, Nankoku-shi, Kochi.
Tel
088-880-2459
jm-c-harada@kochi-u.ac.jp
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
高知大学医学部附属病院（高知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | 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
| 2018 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2018 | Year | 06 | Month | 08 | Day |
Last modified on
| 2021 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037540
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
