Pain ManagementNCT05488834
Nurse-led Pain Management in Adult ICU
A study testing Critical-Care Pain Observation Tool in people with Pain Management, run by King Abdulaziz Medical City at 1 site in Saudi Arabia.
Trial summary
This project is about implementing a pain scale, the Critical Care Pain Observation Tool (CPOT), in ICU settings at King Abdullah Medical City to evaluate its impact on nurse pain assessment and management. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- Critical-Care Pain Observation Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2022to 1 Jul 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient's who are 18 years and above
- Patients must be discharged from ICU
- Working in ICU
- Understand English language
Who cannot join
- Patient's who are on muscle relaxants
- Nurses survey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse-led Pain Management in Adult ICU; A Randomised Stepped-Wedge Hybrid Effectiveness Trial
This project is about implementing a pain scale, the Critical Care Pain Observation Tool (CPOT), in ICU settings at King Abdullah Medical City to evaluate its impact on nurse pain assessment and management.
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.
Read the detailed description
This project is about implementing a pain scale, Critical Care Pain Observation Tool (CPOT), in 8 adult ICUs in King Abdullah Medical City to evaluate the impact on nurse pain assessment and management.
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
- Pain Management
- Being tested
- Critical-Care Pain Observation Tool
- Keywords
- pain, ICU, critical care, nurses, pain assessment, CPOT
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical-Care Pain Observation ToolOther
Also called CPOT
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive care units | Other | 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. Receives: Other: Critical-Care Pain Observation Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of documented pain assessments per 24-hour period
How many times pain is documented and reassessed then charted in the medical file for a non-verbal patient over a 24 hour period.
Measured: 6 months
Secondary outcomes (6)
Level of sedation and analgesia
Measurement of the amount of sedation and analgesics administered to patients. For opioids such as Morphine, the Morphine equivalent units (MME) will be used to standardise the level of analgesia given per day. Other opioids will be equalised to Morphine using this formula: MME/day = Dosage X Doses per day X MME conversion Factor (Sinha et al., 2017).
Measured: 6 months
Length of intubation (LOI)
The LOI is the total time a patient was intubated and invasively ventilated.
Measured: 6 months
ICU stay
The ICU stay is the total time in days that the patient was been admitted to the ICU.
Measured: 6 months
Acceptability
To measure the acceptability of the CPOT intervention, the candidate will apply the post-intervention survey and measure how acceptable the CPOT is to nurses working in the ICUs.
Measured: 6 months
Appropriateness
To measure the perceived fit, compatibility or relevance of the CPOT intervention to nurses working in the ICUs using the post-intervention survey.
Measured: 6 months
Feasibility in nursing practice
To measure how feasible it is to implement the CPOT intervention within the ICUs using the post-intervention survey
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start1 Feb 2022
- Primary completion30 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- A hybrid effectiveness-implementation design will be used in this study. This study will use type (III) hybrid effectiveness implementation strategy. The Critical Care Pain Observation Tool (CPOT) is a pain scale tool used to assess pain in critically ill patients who are incapable of reporting pain. CPOT will be implemented in the eight adult ICUs, and at the same time, data will be collected to measure the intervention's effectiveness.
- Masking
- None (open label)
- Enrolment
- 880 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz Medical City
- Sponsor type
- Other government
- Collaborators
- Newcastle University, Qassim University
- Responsible party
- Principal investigator, Majid Alotni, Newcastle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488834
- Sponsor's protocol ID
- KingAbdulazizMC
- Status last verified
- Aug 2022
- First submitted
- 14 Jun 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39489653
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-led Pain Management in Adult ICU; A Randomised Stepped-Wedge Hybrid Effectiveness Trial
- ClinicalTrials.gov ID
- NCT05488834
- Acronym / sponsor ID
- KingAbdulazizMC
- Conditions
- Pain Management
- Keywords
- pain, ICU, critical care, nurses, pain assessment, CPOT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 880 participants (actual)
- Lead sponsor
- King Abdulaziz Medical CityOther government
- Collaborators
- Newcastle University, Qassim University
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 5 Aug 2022 (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.
This project is about implementing a pain scale, the Critical Care Pain Observation Tool (CPOT), in ICU settings at King Abdullah Medical City to evaluate its impact on nurse pain assessment and management.
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.
Detailed description
This project is about implementing a pain scale, Critical Care Pain Observation Tool (CPOT), in 8 adult ICUs in King Abdullah Medical City to evaluate the impact on nurse pain assessment and management.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A hybrid effectiveness-implementation design will be used in this study. This study will use type (III) hybrid effectiveness implementation strategy. The Critical Care Pain Observation Tool (CPOT) is a pain scale tool used to assess pain in critically ill patients who are incapable of reporting pain. CPOT will be implemented in the eight adult ICUs, and at the same time, data will be collected to measure the intervention's effectiveness.
| Arm | Type | Receives |
|---|---|---|
| Intensive care units | Other | Other: Critical-Care Pain Observation ToolThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient's who are 18 years and above
- Patients must be discharged from ICU
- Working in ICU
- Understand English language
Key exclusion criteria (2 listed)
- Patient's who are on muscle relaxants
- Nurses survey
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 ToolAlso: CPOTThe 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 | Intensive care units |
Primary outcome
Number of documented pain assessments per 24-hour period
Time frame: 6 months
How many times pain is documented and reassessed then charted in the medical file for a non-verbal patient over a 24 hour period.
6 secondary outcomes
Level of sedation and analgesia
Time frame: 6 months
Length of intubation (LOI)
Time frame: 6 months
ICU stay
Time frame: 6 months
Acceptability
Time frame: 6 months
Appropriateness
Time frame: 6 months
Feasibility in nursing practice
Time frame: 6 months
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 5 Aug 2022.
- Derived from this study: PubMed 39489653Alotni 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Management, run by King Abdulaziz Medical City at 1 site in Saudi Arabia.
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 2 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 5 Aug 2022. 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 Saudi Arabia. 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?
Number of documented pain assessments per 24-hour period (time frame: 6 months). 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 NCT05488834, which also lists 1 linked publication.
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 5 Aug 2022.