NCT03654443 - Validation of the Critical-Care Pain Observation Tool (CPOT) in the Greek Population | Crick | Crick

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

N/ASuspendedNCT03654443

Saint Savvas Anticancer Hospital74 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

74

Conditions

Pain Intensive Care Units

Interventions

Critical care pain observation toolDIAGNOSTIC_TEST

The CPOT tool is administered in a crossover manner by two study observers

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Saint Savvas Anticancer Hospital of Athens

Athens, Greece

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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