NCT03654443

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

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Saint Savvas Anticancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Intensive Care Units

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Critical care pain observation tool	The CPOT tool is administered in a crossover manner by two study observers

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-10-01
• Completion: 2021-01-01
• First posted: 2018-08-31
• Last updated: 2020-03-31

Locations

1 site across 1 country: Greece