Pain, AcutePOL-BPSNCT03127306
Validation of the Polish Version of BPS (POL-BPS).
An observational study of Pain, Acute, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
Between 40 to 70% of patients with critical illness experience moderate to severe pain. Diagnosing pain and assessing its severity is difficult in non-verbal patients both in an Intensive Care Unit and in Postoperative Unit after a major surgery such as cardiac surgery). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Assessment of Polish version of BPS
- How many people
- 59 participants
- Where
- 1 sitePoland
- Study dates
- 12 Jun 2017to 30 Aug 2017
- Phase
- Observational
- 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
Study population: Intubated adult ICU patients at the Postoperative Cardiac Surgery Unit of the tertiary teaching hospital at the Pomeranian Medical University in Szczecin, Poland undergoing minimal analgesia-based sedation protocol (dexmedetomidine + morphine intravenous infusion).
Who may be able to join
- Age above 18 years
- Ability to communicate in the Polish language,
- Intubated and mechanically ventilated patients (controlled modes, spontaneous modes),
- Richmond Agitation Sedation Scale (RASS) above or equal to -3,
- Unrestricted sight and hearing,
- No limitations for body position changing,
- After Cardiac surgery
Who cannot join
- A medical need for deep sedation - treatment of severe respiratory failure associated with patient-ventilator dyssynchrony, preventing awareness during neuromuscular blockade, status epilepticus, certain surgical conditions requiring immobility , cases of severe brain injury with intracranial hypertension
- Facial trauma (unable to evaluate facial expression),
- Richmond Agitation Sedation Scale (RASS) -4 or -5
- Neurological or psychiatric disorders,
- Use of neuromuscular blocking agents,
- Regular narcotic users,
- Chronic pain syndrome patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Polish Version of the Behavioral Pain Scale in a Postoperative Cardiac Surgery Unit.
Between 40 to 70% of patients with critical illness experience moderate to severe pain. Diagnosing pain and assessing its severity is difficult in non-verbal patients both in an Intensive Care Unit and in Postoperative Unit after a major surgery such as cardiac surgery). In patients who are unable to self-report pain, we use behavioural pain scales, namely BPS - Behavioural Pain Scale.
Aim: The aim of this study was to validate the Polish version of a behavioural pain assessment method - BPS in intubated, sedated patients after cardiac surgery versus self assessment of pain using Numeric rating scale (NRS) in both delirious and non-delirious patients (assessed using Confusion Assessment Method for ICU, CAM-ICU).
Method: A prospective observational cohort study will include 60 patients. The patients will be observed by two trained observers during a nociceptive procedure (position change), both during analgosedation and analgesia. Patients will be observed 5 minutes before, during, and 15 min after the two sets of interventions (six assessments in total). Each BPS assessment will be carried out by two observers blinded to each other. To validate the Polish BPS translation we will use the following methods: calculations of interrater reliability, criterion validity and discriminant validity.
Read the detailed description
Patients after major surgery, namely cardiac surgery frequently suffer pain during their postoperative stay in the intensive care unit. Nearly 30% of those patients experience pain at rest and up to 50% experience pain during nursing procedures. Pain experienced by critically ill patients falls into four categories that coexist and overlap: pre-existing chronic pain, acute illness-related pain, continuous ICU treatment-related pain or discomfort and intermittent procedural pain. Moreover, acute pain experienced in the ICU may become a chronic problem after discharge from the unit, as a lifelong ICU footprint. Everyday nursing procedures, including position changing performed in the ICU may be a potential source of pain, therefore there is a clinical need for a simple and easy behavioural pain scale to evaluate this condition in patients unable to self assess pain.
Assessment of pain in patients treated in the ICU becomes a daily clinical challenge for the ICU team, also in those units where minimal sedation environment based on analgesia are used. Various guidelines and recommendations exist to guide the ICU care team in the pain management and assessment process. Nevertheless, the gold standard for pain assessment is patient's self-report of pain (using numeric raing scale - NRS), which can be aided with behavioural scales only when the self-report is unreliable or impossible to obtain. Observational pain scales include the Behavioural Pain Scale (BPS) and have been recommended for clinical use in the critically ill adults. However, their validation in a given patient population (cardiac, burn, different languages) is strongly recommended and required.
The need to equip critical care teams (intensive care units - ICUs, high dependency unit - HDUs, Post-Operative Units) with dedicated monitoring tools is clear. The BPS has been developed by critical care professionals and validated in various situations, but it has not been translated or validated in Polish until now.
- Conditions
- Pain, Acute
- Being tested
- Assessment of Polish version of BPS
- Keywords
- Pain, Behavioural Pain Scale, BPS, NRS, Delirium, CAM-ICU
- Medical subject headings
- Acute Pain, Pain, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of Polish version of BPSDiagnostic test
Validation of Polish Version of BPS.
| Study group | Role | What they receive |
|---|---|---|
| CAM-ICU (+) Delirious patients. | Behavioral: BPS assessment
Polish version of BPS tool validation.
Other Names:
Pain assessment in non-verbal patients Receives: Diagnostic Test: Assessment of Polish version of BPS | |
| CAM-ICU (-) Non-delirious patients. | Behavioral: BPS assessment
Polish version of BPS tool validation.
Other Names:
Pain assessment in non-verbal patients Receives: Diagnostic Test: Assessment of Polish version of BPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interrater variability for Polish BPS.
Validation of Polish BPS.
Measured: Through study completion and up to 24 weeks.
Secondary outcomes (2)
Criterion validity for Polish BPS.
Validation od Polish BPS.
Measured: Through study completion and up to 24 weeks.
Discriminant validity for Polish BPS
Validation of Polish BPS.
Measured: Through study completion and up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start12 Jun 2017
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarzyna Kotfis, Pomeranian Medical University Szczecin
- Investigators
- Katarzyna L Kotfis, MD,PhD, Principal investigator, Pomeranian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127306
- Sponsor's protocol ID
- POL-BPS
- Acronym
- POL-BPS
- Status last verified
- Sep 2017
- First submitted
- 20 Apr 2017
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Polish Version of the Behavioral Pain Scale in a Postoperative Cardiac Surgery Unit.
- ClinicalTrials.gov ID
- NCT03127306
- Acronym / sponsor ID
- POL-BPS / POL-BPS
- Conditions
- Pain, Acute
- Keywords
- Pain, Behavioural Pain Scale, BPS, NRS, Delirium, CAM-ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 25 Apr 2017 (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.
Between 40 to 70% of patients with critical illness experience moderate to severe pain. Diagnosing pain and assessing its severity is difficult in non-verbal patients both in an Intensive Care Unit and in Postoperative Unit after a major surgery such as cardiac surgery). In patients who are unable to self-report pain, we use behavioural pain scales, namely BPS - Behavioural Pain Scale.
Aim: The aim of this study was to validate the Polish version of a behavioural pain assessment method - BPS in intubated, sedated patients after cardiac surgery versus self assessment of pain using Numeric rating scale (NRS) in both delirious and non-delirious patients (assessed using Confusion Assessment Method for ICU, CAM-ICU).
Method: A prospective observational cohort study will include 60 patients. The patients will be observed by two trained observers during a nociceptive procedure (position change), both during analgosedation and analgesia. Patients will be observed 5 minutes before, during, and 15 min after the two sets of interventions (six assessments in total). Each BPS assessment will be carried out by two observers blinded to each other. To validate the Polish BPS translation we will use the following methods: calculations of interrater reliability, criterion validity and discriminant validity.
Detailed description
Patients after major surgery, namely cardiac surgery frequently suffer pain during their postoperative stay in the intensive care unit. Nearly 30% of those patients experience pain at rest and up to 50% experience pain during nursing procedures. Pain experienced by critically ill patients falls into four categories that coexist and overlap: pre-existing chronic pain, acute illness-related pain, continuous ICU treatment-related pain or discomfort and intermittent procedural pain. Moreover, acute pain experienced in the ICU may become a chronic problem after discharge from the unit, as a lifelong ICU footprint. Everyday nursing procedures, including position changing performed in the ICU may be a potential source of pain, therefore there is a clinical need for a simple and easy behavioural pain scale to evaluate this condition in patients unable to self assess pain.
Assessment of pain in patients treated in the ICU becomes a daily clinical challenge for the ICU team, also in those units where minimal sedation environment based on analgesia are used. Various guidelines and recommendations exist to guide the ICU care team in the pain management and assessment process. Nevertheless, the gold standard for pain assessment is patient's self-report of pain (using numeric raing scale - NRS), which can be aided with behavioural scales only when the self-report is unreliable or impossible to obtain. Observational pain scales include the Behavioural Pain Scale (BPS) and have been recommended for clinical use in the critically ill adults. However, their validation in a given patient population (cardiac, burn, different languages) is strongly recommended and required.
The need to equip critical care teams (intensive care units - ICUs, high dependency unit - HDUs, Post-Operative Units) with dedicated monitoring tools is clear. The BPS has been developed by critical care professionals and validated in various situations, but it has not been translated or validated in Polish until now.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAM-ICU (+) Delirious patients. | – | Diagnostic Test: Assessment of Polish version of BPSBehavioral: BPS assessment Polish version of BPS tool validation. Other Names: Pain assessment in non-verbal patients |
| CAM-ICU (-) Non-delirious patients. | – | Diagnostic Test: Assessment of Polish version of BPSBehavioral: BPS assessment Polish version of BPS tool validation. Other Names: Pain assessment in non-verbal patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intubated adult ICU patients at the Postoperative Cardiac Surgery Unit of the tertiary teaching hospital at the Pomeranian Medical University in Szczecin, Poland undergoing minimal analgesia-based sedation protocol (dexmedetomidine + morphine intravenous infusion).
Key inclusion criteria (7 listed)
- Age above 18 years
- Ability to communicate in the Polish language,
- Intubated and mechanically ventilated patients (controlled modes, spontaneous modes),
- Richmond Agitation Sedation Scale (RASS) above or equal to -3,
- Unrestricted sight and hearing,
Key exclusion criteria (7 listed)
- A medical need for deep sedation - treatment of severe respiratory failure associated with patient-ventilator dyssynchrony, preventing awareness during neuromuscular blockade, status epilepticus, certain surgical conditions requiring immobility , cases of severe brain injury with intracranial hypertension
- Facial trauma (unable to evaluate facial expression),
- Richmond Agitation Sedation Scale (RASS) -4 or -5
- Neurological or psychiatric disorders,
- Use of neuromuscular blocking agents,
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 |
|---|---|---|
| Assessment of Polish version of BPSValidation of Polish Version of BPS. | Diagnostic test | CAM-ICU (+) Delirious patients., CAM-ICU (-) Non-delirious patients. |
Primary outcome
Interrater variability for Polish BPS.
Time frame: Through study completion and up to 24 weeks.
Validation of Polish BPS.
2 secondary outcomes
Criterion validity for Polish BPS.
Time frame: Through study completion and up to 24 weeks.
Discriminant validity for Polish BPS
Time frame: Through study completion and up to 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- 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.
Katarzyna L Kotfis, MD,PhD principal investigator
Pomeranian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Acute, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 20 Sep 2017. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Interrater variability for Polish BPS. (time frame: Through study completion and up to 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2017.