UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024451 |
|---|---|
| Receipt number | R000028144 |
| Scientific Title | Evaluate of post operative pain in breast cancer with heart rate variability analysis |
| Date of disclosure of the study information | 2016/10/26 |
| Last modified on | 2017/10/06 13:17:16 |
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Basic information
Public title
Evaluate of post operative pain in breast cancer with heart rate variability analysis
Acronym
heart rate variability analysis of post operative pain in breast cancer
Scientific Title
Evaluate of post operative pain in breast cancer with heart rate variability analysis
Scientific Title:Acronym
heart rate variability analysis of post operative pain in breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
evaluation of post operative pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of post operative pain in breast cancer post operative few hours
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
post breast cancer operative patients
Key exclusion criteria
diabetes mellitus
anxiety disorder
operative massive hemorrhage
arrhythmia
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Uchida |
Organization
Gunma prefectural Cancer Center
Division name
anesthesiology
Zip code
Address
617-1 takabayasinisityou oota city gunma pref.
TEL
0276-38-0771
s_uchida@gunma-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Uchida |
Organization
Gunma prefectural Cancer Center
Division name
anesthesiology
Zip code
Address
617-1 takabayasinisityou oota city gunma pref.
TEL
0276-38-0771
Homepage URL
s_uchida@gunma-cc.jp
Sponsor or person
Institute
Gunma prefectural Cancer Center
Department of anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Gunma prefectural Cancer Center
Department of anesthesiology
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 10 | Month | 26 | 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
| 2016 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 07 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 06 | Day |
Other
Other related information
Data analysis was finished.
Management information
Registered date
| 2016 | Year | 10 | Month | 17 | Day |
Last modified on
| 2017 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028144
