UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009002 |
|---|---|
| Receipt number | 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 00:22:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
| 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
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
tatsu-w@med.niigata-u.ac.jp
Sponsor or person
Institute
Nagaoka Red Cross Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010555
