UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023411 |
|---|---|
| Receipt number | R000025577 |
| Scientific Title | The relationship between preoperative sleep disruption and postoperative quality of recovery |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2019/05/03 09:07:15 |
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Basic information
Public title
The relationship between preoperative sleep disruption and postoperative quality of recovery
Acronym
Sleep and postoperative quality of recovery
Scientific Title
The relationship between preoperative sleep disruption and postoperative quality of recovery
Scientific Title:Acronym
Sleep and postoperative quality of recovery
Region
| Japan |
Condition
Condition
malignant disease undergoing gynecological open abdominal surgery
Classification by specialty
| Surgery in general | Obstetrics and Gynecology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate quality of recovery
Basic objectives2
Others
Basic objectives -Others
to evaluate the influence preoperative sleep disruption has on postoperative quality of life, activities of daily living, postoperative dysfunction.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
quality of recovery 40
Key secondary outcomes
postoperative sleep disruption
length of hospital
postoperative complications
reoperation or rehospitalization within 30days
quality of life, activities of daily living, postoperative dysfunction, pain after postoperative 3 months
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Actigraph
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Gynecological open abdominal surgery
surgery under general anesthesia
elective operation
malignancy
Seven or more days of hospitalization is expected
Key exclusion criteria
use of sedatives
Patient with mental illness or neuropathy
Patient preoperative evaluation is difficult
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kawaguchi |
| Middle name | |
| Last name | Masahiko |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
634-8523
Address
840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL
09079627114
nwnh0131@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Ida |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
634-8523
Address
Shijo-machi 840
TEL
09079627114
Homepage URL
nwnh0131@yahoo.co.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
No
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
Nara Medical University
Address
Shijo-machi 840
Tel
0744298902
kakostaaarz@gmail.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
| 2016 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
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
| 2016 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2016 | Year | 07 | Month | 31 | Day |
Last modified on
| 2019 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025577
| 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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