Clinical trial NCT03654443: Validation of the Critical-Care Pain Observation Tool (CPOT) in the Greek Population
Official title: Greek Validation of the Critical-Care Pain Observation Tool (CPOT) in the Intensive Care Unit Setting
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Pain
Intensive Care Units
Lead sponsor: Saint Savvas Anticancer Hospital
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
timeFrame: 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
measure: Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
timeFrame: 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
measure: Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
timeFrame: 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
measure: Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
timeFrame: 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
measure: Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
timeFrame: 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
measure: Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
timeFrame: 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
measure: Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
timeFrame: 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 outcomes:
measure: Correlation of physiological parameters to CPOT tool (Critical Care Pain Observation Tool) values
timeFrame: 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
measure: Correlation of numeric pain rating scale (NPRS) to CPOT tool (Critical Care Pain Observation Tool)values
timeFrame: 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
measure: Correlation of physiological parameters to CPOT tool(Critical Care Pain Observation Tool) values
timeFrame: 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
measure: Correlation of physiological parameters to CPOT tool (Critical Care Pain Observation Tool)values
timeFrame: 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
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Saint Savvas Anticancer Hospital of Athens
Study officials:
affiliation: Saint Savvas Anticancer Hospital of Athens
name: Georgia Micha, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gelinas C, Fillion L, Puntillo KA. Item selection and content validity of the Critical-Care Pain Observation Tool for non-verbal adults. J Adv Nurs. 2009 Jan;65(1):203-16. doi: 10.1111/j.1365-2648.2008.04847.x. Epub 2008 Nov 15.
citation: Kanji S, MacPhee H, Singh A, Johanson C, Fairbairn J, Lloyd T, MacLean R, Rosenberg E. Validation of the Critical Care Pain Observation Tool in Critically Ill Patients With Delirium: A Prospective Cohort Study. Crit Care Med. 2016 May;44(5):943-7. doi: 10.1097/CCM.0000000000001522.