PainNCT03654443
Validation of the Critical-Care Pain Observation Tool (CPOT) in the Greek Population
A study testing Critical care pain observation tool in people with Pain and Intensive Care Units, run by Saint Savvas Anticancer Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Intensive Care Units
- What is being tested?
- Critical care pain observation tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2018to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted in the ICU
- Age> 18 years old
- No hearing or visual deficit
- No contraindication to body repositioning
Who cannot join
- Patients with neurological deficit
- Patients administered with neuromuscular blocking agents
- Patients with motor or sensory deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Greek Validation of the Critical-Care Pain Observation Tool (CPOT) in the Intensive Care Unit Setting
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.
Read the 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
- Being tested
- Critical care pain observation tool
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical care pain observation toolDiagnostic test
The CPOT tool is administered in a crossover manner by two study observers
| Study group | Role | What they receive |
|---|---|---|
| Group Painful stimulus | Experimental | 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) Receives: Diagnostic Test: Critical care pain observation tool |
| Group Non-painful stimulus | Experimental | 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) Receives: Diagnostic Test: Critical care pain observation tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 (4)
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Jul 2018
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Why it stopped: The study is currently suspended due to the COVID19 crisis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Savvas Anticancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgia Micha, Saint Savvas Anticancer Hospital
- Investigators
- Georgia Micha, MD, MSc, PhD, Principal investigator, Saint Savvas Anticancer Hospital of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654443
- Sponsor's protocol ID
- StSavvasAH
- Status last verified
- Mar 2020
- First submitted
- 16 Jun 2018
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19032510Kanji 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.
PubMed 26783859
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Greek Validation of the Critical-Care Pain Observation Tool (CPOT) in the Intensive Care Unit Setting
- ClinicalTrials.gov ID
- NCT03654443
- Acronym / sponsor ID
- StSavvasAH
- Conditions
- Pain, Intensive Care Units
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study is currently suspended due to the COVID19 crisis
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Saint Savvas Anticancer HospitalUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Painful stimulus | Experimental | Diagnostic Test: Critical care pain observation toolThe 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 | Experimental | Diagnostic Test: Critical care pain observation toolThe 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted in the ICU
- Age> 18 years old
- No hearing or visual deficit
- No contraindication to body repositioning
Key exclusion criteria (3 listed)
- Patients with neurological deficit
- Patients administered with neuromuscular blocking agents
- Patients with motor or sensory deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Critical care pain observation toolThe CPOT tool is administered in a crossover manner by two study observers | Diagnostic test | Group Non-painful stimulus, Group Painful stimulus |
Primary outcome
Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
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
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.
Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
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
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.
Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
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
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.
Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
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
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.
Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
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
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.
Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
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
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.
Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients
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
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.
4 secondary outcomes
Correlation of physiological parameters to CPOT tool (Critical Care Pain Observation Tool) values
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Background: PubMed 19032510Gelinas 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.
- Background: PubMed 26783859Kanji 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgia Micha, MD, MSc, PhD principal investigator
Saint Savvas Anticancer Hospital of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Critical care pain observation tool in people with Pain and Intensive Care Units, run by Saint Savvas Anticancer Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Greek validation of the CPOT tool (Critical Care Pain Observation Tool) in the ICU patients (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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03654443, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.