UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the diagnostic accuracy of nonverbal signs used by medical staff to assess postoperative pain A prospective study
Title of the study (Brief title)	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	Tsuyoshi Sato
Organization	Nagaoka Red Cross Hospital
Division name	Department of Anesthesiology
Address	2-297-1 Sensyu, Nagaoka, 940-2085, Japan
TEL	0258-28-3600
Email	sakuibuan@yahoo.co.jp

Public contact
Name of contact person	Tatsunori Watanabe
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Anesthesiology
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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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