UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020213 |
|---|---|
| Receipt number | R000023345 |
| Scientific Title | Research of improvement effect of postoperative persistent pain with a "healthy life expectancy stretched box" |
| Date of disclosure of the study information | 2015/12/16 |
| Last modified on | 2018/12/29 20:37:16 |
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Basic information
Public title
Research of improvement effect of postoperative persistent pain with a "healthy life expectancy stretched box"
Acronym
Postoperative persistent pain and healthy life expectancy stretched box
Scientific Title
Research of improvement effect of postoperative persistent pain with a "healthy life expectancy stretched box"
Scientific Title:Acronym
Postoperative persistent pain and healthy life expectancy stretched box
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To target the patients with postoperative persistent pain, we will investigate effective of healthy life expectancy stretched box for improving cancer pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain assessment by NRS and QOL assessment by the SF-36 ver.2 and evaluation of the stress level of patients by the salivary amylase monitor.
we will assess before and after to enter the healthy life expectancy stretched box
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Before healthy extension life box admission, we will measure pain evaluation and the QOL evaluation, a saliva amylase level of the patient.We will let patients enter the healthy life expectancy extension box.
We will measure pain evaluation and the saliva amylase level after box admission.
We will let patients enter the healthy life expectancy extension box after 2~3 day.
We will measure pain evaluation and the saliva amylase level after box admission.
After 2~3 days, healthy extension life box admission, we will measure pain evaluation and the QOL evaluation, a saliva amylase level of the patient.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Tumor-bearing patients under 20 years of age or 75 years of age.
Patients who are received a diagnosis of postoperative persistent pain.
Patients who are the intensity of the pain of 3-8 in the numerical rating scale (NRS).
After receiving a sufficient explanation upon participation in this study, patients who consent was obtained by the document based on the free will of the patient himself.
Key exclusion criteria
Patients complain of difficulty breathing.
Patients with pleural effusion or ascites requiring drainage.
Patients with history for ischemic heart disease and aortic valve stenosis of heart failure, obstructive hypertrophic cardiomyopathy.
Patients with a history of cooped-up feeling and breathing difficulties in the sauna entrance.
Female patient of pregnant or lactating.
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maruyama Yuki |
Organization
Shinshu university school of medicine
Division name
The department of Anesthesiology and Resuscitology
Zip code
Address
Matsumoto, Nagano Prefecture Asahi 3-1-1
TEL
0263-37-2670
yukio.afternoon.tea@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maruyama Yuki |
Organization
Shinshu university school of medicine
Division name
The department of Anesthesiology and Resuscitology
Zip code
Address
Matsumoto, Nagano Prefecture Asahi 3-1-1
TEL
0263-37-2670
Homepage URL
yukio.afternoon.tea@gmail.com
Sponsor or person
Institute
Department of comprehensive cancer therapy, Shinshu university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of comprehensive cancer therapy, Shinshu university school of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ltd. Water Life
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
| 2015 | Year | 12 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 16 | 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
Management information
Registered date
| 2015 | Year | 12 | Month | 16 | Day |
Last modified on
| 2018 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023345
