Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
880 participants
INTERVENTIONAL
2022-02-01
2022-07-01
Brief Summary
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Pain is considered as a significant problem in ICU and the literature shows that 50% of patients in ICU suffer moderate to severe pain and up to 70% of patients experience undetected pain while in ICU. The CPOT is an evidence-based intervention to assess pain among non-verbal patients in ICU settings. A stepped-Wedge Randomised trial will be used to implement the CPOT in 8 ICU in King Abduullah Medical City. Patient chart audits and a survey of ICU nurses will be conducted post implementation.
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Detailed Description
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The literature shows that pain is perceived to be one of the most concerning issues in ICU and that 50% of patients in the ICU suffer moderate to severe pain. In addition, 70% of patients have undetected pain while admitted to ICU. Evidence-based guidelines suggest that CPOT is the most reliable and efficient pain scale tool for non-verbal patients in ICUs, and it is recommended in countries such as the USA, Canada, Australia and New Zealand. The literature suggests that CPOT has a positive impact on frequency of pain assessment.
A Stepped-Wedge Randomised trial will be used to implement the CPOT and at the same time assess the effectiveness of CPOT on pain assessment frequency and management. Patient charts will be audited, and a survey of nurses will be undertaken post CPOT implementation to assess the CPOT acceptability, appropriateness and feasibility.
Conditions
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Study Design
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NA
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Intensive care units
The unit will be subject to the intervention. Data will be collected from all 8 units in the control phase of this study. Units will then be randomised in blocks to the intervention.
Critical-Care Pain Observation Tool
The Critical Care Pain Observation Tool (CPOT) was created to help assess pain in critically ill patients who were unable to self-report pain.
The CPOT instrument evaluates facial expression, body movement, muscle tension, and compliance with ventilator or vocalisation to evaluate an individual's pain. The total score ranges from 0 to 8, where 8 is the worst pain. Patients are observed for 60 seconds while resting and during nociceptive procedures such as turning or wound dressings to detect any change in behaviour that could indicate pain. Further, the patient must be observed before and at the peak of analgesia medications administered to evaluate pain treatment effectiveness.
Interventions
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Critical-Care Pain Observation Tool
The Critical Care Pain Observation Tool (CPOT) was created to help assess pain in critically ill patients who were unable to self-report pain.
The CPOT instrument evaluates facial expression, body movement, muscle tension, and compliance with ventilator or vocalisation to evaluate an individual's pain. The total score ranges from 0 to 8, where 8 is the worst pain. Patients are observed for 60 seconds while resting and during nociceptive procedures such as turning or wound dressings to detect any change in behaviour that could indicate pain. Further, the patient must be observed before and at the peak of analgesia medications administered to evaluate pain treatment effectiveness.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be discharged from ICU
* Working in ICU
* Understand English language
Exclusion Criteria
Nurses survey
18 Years
ALL
Yes
Sponsors
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Newcastle University
OTHER
Qassim University
OTHER
King Abdulaziz Medical City
OTHER_GOV
Responsible Party
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Majid Alotni
PhD student
Locations
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King Abdulaziz Medical City
Riyadh, , Saudi Arabia
Countries
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References
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Alotni MA, Sim J, Chu G, Guilhermino M, Barker D, Szwec S, Fernandez R. Impact of implementing the critical-care pain observation tool in the adult intensive care unit: A nonrandomised stepped-wedge trial. Aust Crit Care. 2025 Mar;38(2):101129. doi: 10.1016/j.aucc.2024.09.014. Epub 2024 Nov 2.
Other Identifiers
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KingAbdulazizMC
Identifier Type: -
Identifier Source: org_study_id
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