Validation of the Critical-Care Pain Observation Tool (CPOT) in the Greek Population

Study Overview
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Brief Summary
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The aim of this study is to validate the Critical-Care Pain Observation Tool (CPOT) in the setting of the Intensive care unit (ICU). Prior to patient recruitment the tool will be translated by the method of translation-back translation by Greek and English native speakers. The tool will be administered to patients who are admitted into the ICU.

Detailed Description
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The aim of this study is to validate the Critical-Care Pain Observation Tool (CPOT) in the setting of the Intensive care unit (ICU). Prior to patient recruitment the tool will be translated by the method of translation-back translation by Greek and English native speakers. The study is designed as a prospective randomized crossover clinical trial. Patients will be randomly allocated into two study groups. In Group I the CPOT tool is administered prior to a painful stimulus (ITime0), during the painful stimulus (ITime1) and soon afterwards (ITime2).In Group II the CPOT tool is administered prior to a non painful stimulus(IITime0), during a non-painful stimulus (IITime1) and soon afterwards (IITime2). After these trials the patients in the two groups will crossover into the other group and the whole process will be repeated. The painful stimulus is set to be the passive turning of the patient into the bed and the non painful stimulus is the cleaning of the arm or leg. 20 minutes afterwards the CPOT tool is administered once again in both groups in order to obtain the values when there is no stimulus (ITime3). The tool is administered by two trained members of the study team in a blind manner. Both of the observers administer the tool at the same time but one of them is positioned in the ward of the patient and the other one behind a curtain with no contact with the observer but only with the patient and the monitor.

Official Title
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Greek Validation of the Critical-Care Pain Observation Tool (CPOT) in the Intensive Care Unit Setting

Conditions
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Pain, Intensive Care Units

Intervention / Treatment
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* Diagnostic Test: Critical care pain observation tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted in the ICU Age> 18 years old No hearing or visual deficit No contraindication to body repositioning Exclusion Criteria: Patients with neurological deficit Patients administered with neuromuscular blocking agents Patients with motor or sensory deficits

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Painful stimulus<br>The CPOT tool is administered in a crossover manner in Group one prior to a painful stimulus (IT0), during the painful stimulus (IT1) and soon afterwards (IT2) | Diagnostic Test: Critical care pain observation tool<br>* The CPOT tool is administered in a crossover manner by two study observers<br>|
| Experimental: Group Non-painful stimulus<br>The CPOT tool is administered in a crossover manner in Group one prior to a non-painful stimulus (IIT0), during the painful stimulus (IIT1) and soon afterwards (IIT2) | Diagnostic Test: Critical care pain observation tool<br>* The CPOT tool is administered in a crossover manner by two study observers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients | Validation of the Greek version of the CPOT tool (Critical Care Pain Observation Tool) for assessing the pain in the intensive care unit patients.Maximum score 8 points.For those patients with a CPOT score of ≤ 2:There is likely minimal to no pain present.For those patients with a CPOT score of >2:There is a medium to severe level of pain. | The CPOT tool (Critical Care Pain Observation Tool) is administered 1 minute prior to a painful stimulus (ITime0) which is set to be the patient's bed repositioning | 
| Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients | Validation of the Greek version of the CPOT tool (Critical Care Pain Observation Tool) for assessing the pain in the intensive care unit patients.Maximum score 8 points.For those patients with a CPOT score of ≤ 2:There is likely minimal to no pain present.For those patients with a CPOT score of >2:There is a medium to severe level of pain. | The CPOT tool(Critical Care Pain Observation Tool) is administered 10 seconds after a painful stimulus (ITime1) which is set to be the patient's bed repositioning | 
| Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients | Validation of the Greek version of the CPOT tool (Critical Care Pain Observation Tool) for assessing the pain in the intensive care unit patients.Maximum score 8 points.For those patients with a CPOT score of ≤ 2:There is likely minimal to no pain present.For those patients with a CPOT score of >2:There is a medium to severe level of pain. | The CPOT tool(Critical Care Pain Observation Tool) is administered 1 minute after a painful stimulus (ITime2) which is set to be the patient's bed repositioning | 
| Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients | Validation of the Greek version of the CPOT tool (Critical Care Pain Observation Tool) for assessing the pain in the intensive care unit patients.Maximum score 8 points.For those patients with a CPOT score of ≤ 2:There is likely minimal to no pain present.For those patients with a CPOT score of >2:There is a medium to severe level of pain. | The CPOT tool (Critical Care Pain Observation Tool)is administered 20 minutes after a painful stimulus (ITime3) which is set to be the patient's bed repositioning | 
| Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients | Validation of the Greek version of the CPOT tool (Critical Care Pain Observation Tool) for assessing the pain in the intensive care unit patients.Maximum score 8 points.For those patients with a CPOT score of ≤ 2:There is likely minimal to no pain present.For those patients with a CPOT score of >2:There is a medium to severe level of pain. | The CPOT tool (Critical Care Pain Observation Tool)is administered 1 minute prior to a non painful stimulus (IITime0) which is set to be the patient's blood pressure measurement | 
| Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients | Validation of the Greek version of the CPOT tool (Critical Care Pain Observation Tool) for assessing the pain in the intensive care unit patients.Maximum score 8 points.For those patients with a CPOT score of ≤ 2:There is likely minimal to no pain present.For those patients with a CPOT score of >2:There is a medium to severe level of pain. | The CPOT tool(Critical Care Pain Observation Tool) is administered 10 seconds after a non painful stimulus (IITime1) which is set to be the patient's blood pressure measurement | 
| Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients | Validation of the Greek version of the CPOT tool (Critical Care Pain Observation Tool) for assessing the pain in the intensive care unit patients.Maximum score 8 points.For those patients with a CPOT score of ≤ 2:There is likely minimal to no pain present.For those patients with a CPOT score of >2:There is a medium to severe level of pain. | The CPOT tool (Critical Care Pain Observation Tool)is administered 1 minute after a painful stimulus (IITime2) which is set to be the patient's blood pressure measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of physiological parameters to CPOT tool (Critical Care Pain Observation Tool) values | Physiological parameters as mean arterial blood pressure (MAP in mmHg) will be recorded in all patients. In order to calculate the mean arterial pressure, systolic and diastolic pressures will be recorded in the time periods of the assessment. | The recordings will be performed 1 minute before, 10 seconds after, 1 minute after and 20 minutes after a painful and a non painful stimulus | 
| Correlation of numeric pain rating scale (NPRS) to CPOT tool (Critical Care Pain Observation Tool)values | NPRS scale (0 equals no pain and 10 equals maximum pain possible)will be performed in all patients that are able to communicate in order to correlate the results with those of the CPOT tool | The recordings will be performed 1 minute before, 10 seconds after, 1 minute after and 20 minutes after a painful and a non painful stimulus | 
| Correlation of physiological parameters to CPOT tool(Critical Care Pain Observation Tool) values | Physiological parameters as heart rate will be recorded in all patients. | The recordings will be performed 1 minute before, 10 seconds after, 1 minute after and 20 minutes after a painful and a non painful stimulus | 
| Correlation of physiological parameters to CPOT tool (Critical Care Pain Observation Tool)values | Physiological parameters as respiratory rate will be recorded in all patients | The recordings will be performed 1 minute before, 10 seconds after, 1 minute after and 20 minutes after a painful and a non painful stimulus |