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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020213
Receipt No. 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

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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
Email 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
Email yukio.afternoon.tea@gmail.com

Sponsor
Institute Department of comprehensive cancer therapy, Shinshu university school of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023345

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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