An interventional study of Critical care pain observation tool in Pain and Intensive Care Units, sponsored by Saint Savvas Anticancer Hospital. Suspended at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-31.
Sponsored by Saint Savvas Anticancer Hospital · Not applicable, Interventional, and Other
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.
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's planned enrollment of 74 is close to the median of 70 across 1,904 interventional studies indexed under Pain.
Browse Pain studies →Saint Savvas Anticancer Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Diagnostic Test: 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)
Diagnostic Test: Critical care pain observation tool
The CPOT tool is administered in a crossover manner by two study observers
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.
Time frame: 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
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 non painful stimulus (IITime0) which is set to be the patient's blood pressure measurement
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 non painful stimulus (IITime1) which is set to be the patient's blood pressure measurement
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 (IITime2) which is set to be the patient's blood pressure measurement
Correlation of physiological parameters to CPOT tool (Critical Care Pain Observation Tool) values
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.
Time frame: 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
Correlation of numeric pain rating scale (NPRS) to CPOT tool (Critical Care Pain Observation Tool)values
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
Time frame: 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
Correlation of physiological parameters to CPOT tool(Critical Care Pain Observation Tool) values
Physiological parameters as heart rate will be recorded in all patients.
Time frame: 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
Correlation of physiological parameters to CPOT tool (Critical Care Pain Observation Tool)values
Physiological parameters as respiratory rate will be recorded in all patients
Time frame: 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
Plan to share: Undecided
This study is suspended, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Saint Savvas Anticancer Hospital