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

Not Applicable

Suspended

• Conditions: Pain; Intensive Care Units
• Interventions: Diagnostic Test: Critical care pain observation tool

• Registration Number: NCT03654443
• Lead Sponsor: Saint Savvas Anticancer Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-06-16
• Study Start: 2018-07-01
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-28
• Last Update Posted: 2020-03-31
• Primary Completion: 2020-10-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group Painful stimulus	Critical care pain observation tool	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)
Group Non-painful stimulus	Critical care pain observation tool	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)

Primary Outcome Measures

Name	Time	Method
Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients	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	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.

Secondary Outcome Measures

Name	Time	Method
Correlation of physiological parameters to CPOT tool (Critical Care Pain Observation Tool) values	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	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.
Correlation of numeric pain rating scale (NPRS) to CPOT tool (Critical Care Pain Observation Tool)values	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	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
Correlation of physiological parameters to CPOT tool (Critical Care Pain Observation Tool)values	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	Physiological parameters as respiratory rate will be recorded in all patients
Correlation of physiological parameters to CPOT tool(Critical Care Pain Observation Tool) values	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	Physiological parameters as heart rate will be recorded in all patients.

Trial Locations

Locations (1)

Saint Savvas Anticancer Hospital of Athens; 🇬🇷 Athens, Greece