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Recruitment status Completed
Unique ID issued by UMIN UMIN000009002
Receipt No. R000010555
Scientific Title Evaluation of the diagnostic accuracy of nonverbal signs used by medical staff to assess postoperative pain A prospective study
Date of disclosure of the study information 2012/09/28
Last modified on 2016/11/28

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Basic information
Public title Evaluation of the diagnostic accuracy of
nonverbal signs used by medical staff to
assess postoperative pain
A prospective study
Acronym Evaluation of the diagnostic accuracy of
nonverbal signs used by medical staff to
assess postoperative pain
A prospective study
Scientific Title Evaluation of the diagnostic accuracy of
nonverbal signs used by medical staff to
assess postoperative pain
A prospective study
Scientific Title:Acronym Evaluation of the diagnostic accuracy of
nonverbal signs used by medical staff to
assess postoperative pain
A prospective study
Region
Japan

Condition
Condition elective non-cardiac surgery
Classification by specialty
Surgery in general Anesthesiology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Medical workers tend to underestimate pain in postoperative patients. The reason may be because they evaluate the patient's pain mostly by his/her pain behavior.
If there is a complete correlation between the degree of pain and pain behavior, then there is probably no underestimation of pain. However, the reality may be different and the underestimation of pain may occur.
We hypothesize that pain behaviors do not appear when patients experience 'strong but tolerable pain' and using NRS can evaluate postoperative pain in this range more correctly than using assessment of pain behavior.
The purpose of this study is to demonstrate that validity of NRS to prevent underestimation of actual pain
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostiv accuracy of non verbal signs of pain, verbal complaints and NRS
Sensitivities and Specificities of the each items included in non verbal signs of pain and verbal complaints
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing elective non-cardiac surgery and patients admitted to ICU after surgery
Key exclusion criteria Patients with communication disorder before surgery
Patients in whom evaluators could not rate pain because of the circumstances of their work
Patients with postoperative delirium
Patients anable to understand NRS
Patients who leftICU halfway
Patients with postoperative sudden change in their condition
Patients admitted to the ICU while being intubated
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Sato
Organization Nagaoka Red Cross Hospital
Division name Department of Anesthesiology
Zip code
Address 2-297-1 Sensyu, Nagaoka, 940-2085, Japan
TEL 0258-28-3600
Email sakuibuan@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsunori Watanabe
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Anesthesiology
Zip code
Address 1-757 Asahimachidori, Chuo-ku, Niigata 951-8510, Japan
TEL 025-227-2328
Homepage URL
Email tatsu-w@med.niigata-u.ac.jp

Sponsor
Institute Nagaoka Red Cross Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization None
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
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 長岡赤十字病院(新潟県)

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 28 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
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
2012 Year 09 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We hypothesize that pain behaviors do not appear when patients experience 'strong but tolerable pain' and using NRS can evaluate postoperative pain in this range more correctly than assessment of pain behavior.
We examine this hypothesis to demonstrate validity of NRS.

Management information
Registered date
2012 Year 09 Month 28 Day
Last modified on
2016 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010555


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