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

Saint Savvas Anticancer Hospital

Status: Suspended

Conditions: Intensive Care Units; Pain

Treatments: Diagnostic Test: Critical care pain observation tool

Study type: Interventional

Funder types: Other

Identifiers

NCT03654443

StSavvasAH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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74 participants in 2 patient groups

Group Painful stimulus

Experimental group

Description:

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)

Treatment:

Diagnostic Test: Critical care pain observation tool

Group Non-painful stimulus

Experimental group

Description:

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)

Treatment:

Diagnostic Test: Critical care pain observation tool