UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013488 |
|---|---|
| Receipt number | R000015752 |
| Scientific Title | The association of preoperative psychological stress with postsurgical chronic pain in patients scheduled for partial mastectomy |
| Date of disclosure of the study information | 2014/03/24 |
| Last modified on | 2016/03/27 15:15:16 |
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Basic information
Public title
The association of preoperative psychological stress with postsurgical chronic pain in patients scheduled for partial mastectomy
Acronym
The association of preoperative psychological stress with postsurgical chronic pain in patients scheduled for partial mastectomy
Scientific Title
The association of preoperative psychological stress with postsurgical chronic pain in patients scheduled for partial mastectomy
Scientific Title:Acronym
The association of preoperative psychological stress with postsurgical chronic pain in patients scheduled for partial mastectomy
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association of preoperative anxiety and/or depression and stress hormone with postsurgical chronic pain in patients scheduled for partial mastectomy.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before surgery, the patients filled in a questionnaire about anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). As a biomarker of psychological stress, 24-hour urine cortisol was measured 2 days before surgery. Postsurgical chronic pain was assessed 1, 3, and 6 months after surgery by the short-form McGill Pain Questionnaire,
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
dexamethason suppressiontest
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
patients scheduled for partial mastectomy
Key exclusion criteria
preoperative chemotherapy and radiotherapy, recurrence of cancer, infectious disease, cataract,glaucoma, electrolyte abnormality, diabetes, not general anesthesia
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | saori hashiguchi |
Organization
keio university
Division name
department of anesthesiology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo Japan 1608582
TEL
03-3353-1211
saori-h@z3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | daisuke nishimura |
Organization
keio university
Division name
department of anesthesiology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo Japan 1608582
TEL
03-3353-1211
Homepage URL
dn246@yahoo.co.jp
Sponsor or person
Institute
keio university
Institute
Department
Personal name
Funding Source
Organization
scientific research fund
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
| 2014 | Year | 03 | Month | 24 | 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
| 2014 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 23 | Day |
Last modified on
| 2016 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015752
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
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