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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023411
Receipt No. 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

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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 Obsterics 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
Email 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
Email nwnh0131@yahoo.co.jp

Sponsor
Institute Nara Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025577

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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