The Effects of a Systematic Pain Assessment Approach on Critically Ill Patients Outcomes in ICU

May 2, 2015 updated by: Evanthia Georgiou, Cyprus University of Technology

The Effects of a Systematic Pain Assessment Approach on Critically Ill Patients Outcomes: A Randomized Interventional Clinical Study

The purpose of this study is to investigate the effectiveness of a systematic approach to pain assessment in the critically ill patients' outcome The investigators hypothesize that, patients who will undergo systematic pain assessment and they will have their results notified to physicians and nurses, will demonstrate favorable effects on pain intensity, more efficient use of sedatives and analgesics, duration of mechanical ventilation, length of ICU stay, mortality, adverse events and complications, in relation to patients who will receive standard care alone. Moreover it is expected that they will demonstrate altered levels of plasma neuropeptides and biochemical markers in peripheral blood.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Appropriate pain management depends on the systematic and comprehensive assessment of pain. Inaccurate pain assessment and the resulting inadequate treatment of pain in critically ill adults can have significant physiological and psychological consequences.

The investigators will examine whether a systematic pain assessment approach can improve patients outcomes.

120 ICU patients will be randomized either to control or intervention group. The control group will receive standard care plus pain assessments but nurses and physicians will be blind of these results. The intervention group will receive standard care plus systematic pain assessment and the results will be notified to nurses and physicians.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Cyprus
      • Nicosia, Cyprus
        • Recruiting
        • Nicosia General Hospital
        • Contact:
        • Principal Investigator:
          • Evanthia G Georgiou, PhD cand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years and older
  • All patients with an estimated source of pain or due to immunological process as trauma, surgery, or due to general factors such as endotracheal intubation, interventional catheters

Exclusion Criteria:

  • Length of stay in the ICU <24 hours
  • The patient receives neuromuscular blockers,
  • The patient has a disease or condition, such as Guillain-Barre, peripheral neuropathy, which modifies sensory transmission of painful stimuli
  • The patient has a disease or condition which complicates the assessment of pain behavior, such as decerebration or vegetative state, agitation> 3 in the Richmond Agitation sedation Scale (RASS)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group

Intervention:

  1. systematic pain assessment
  2. Notification of results of assessments to nurses and physicians. Pain Assessments will be done with the use of 2 different behavioral pain tools by independent assessors and the results of the assessments will be notified to the nurses and physicians and their respond will be observed and documented
Other: Systematic pain assessment
Systematic assessment of pain twice daily with the use of 2 different behavioral pain tools (Behavioral Pain Scale - BPS, and Critical Care Pain Observation Tool - C-POT) for non-communicative patients and Numerical Rating Scale (NRS) 1-10 for communicative patients.
Other: Notification of results of assessments
Pain assessments will be carried out by independent investigators who will notify the results to ICU nurses and physicians and observe and document their reaction
Active Comparator: Control Group
Intervention. Systematic pain assessments. Assessments of pain will be done by independent assessors but results will not be notified to nurses or physicians
Other: Systematic pain assessment
Systematic assessment of pain twice daily with the use of 2 different behavioral pain tools (Behavioral Pain Scale - BPS, and Critical Care Pain Observation Tool - C-POT) for non-communicative patients and Numerical Rating Scale (NRS) 1-10 for communicative patients.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
a) Level of pain (intensity, incidence of high levels of pain with a numerical pain scale NRS> 6, Behavioral pain scale (BPS) > 5 and Critical pain observation Tool (C-POT) >2
Time Frame: morning between 9:00-11: hrs, and afternoon between 4:00-6:00 hrs) for ten continuous days
morning between 9:00-11: hrs, and afternoon between 4:00-6:00 hrs) for ten continuous days
To investigate the effect of the systematic assessment of pain among patients groups - control and intervention as to:The total dose, frequency of administration and the type of analgesics and sedatives received
Time Frame: every 24 hrs for ten continuous days
every 24 hrs for ten continuous days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Effect of the systematic evaluation of pain among patients groups - control and intervention as to:The degree of sedation/agitation
Time Frame: morning between 9:00-11: hrs, and afternoon between 4:00-6:00 hrs) for ten continuous days
morning between 9:00-11: hrs, and afternoon between 4:00-6:00 hrs) for ten continuous days
Effect of the systematic evaluation of pain among patients groups - control and intervention as to:The levels of biochemical marker, cortisol, in the serum
Time Frame: morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample)
morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample)
Effect of the systematic evaluation of pain among patients groups - control and intervention as to:The levels of biochemical marker corticotrophin hormone -ACTH in the serum
Time Frame: morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample)
morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample)
Effect of the systematic evaluation of pain among patients groups - control and intervention as to: The levels of biochemical marker, b-endorphin in the serum
Time Frame: morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample)
morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample)
Effect of the systematic evaluation of pain among patients groups - control and intervention as to: The levels of neuropeptide Y
Time Frame: morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample)
morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample)
Effect of the systematic evaluation of pain among patients groups - control and intervention as to: The levels of neuropeptide , substance P in the serum
Time Frame: morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample)
morning 1st day intervention (one sample), 3rd day intervention (second sample), 5th day intervention (third sample)
To investigate the effect of the systematic assessment of pain among patients groups - control and intervention as to duration of mechanical ventilation
Time Frame: Day and time of initiation of mechanical ventilation till the day and time of end of mechanical ventilation, up to six months.
Day and time of initiation of mechanical ventilation till the day and time of end of mechanical ventilation, up to six months.
To investigate the effect of the systematic assessment of pain among patients groups - control and intervention as to length of stay in the ICU
Time Frame: From the day of admission to ICU till the day of discharge from ICU, up to six months
From the day of admission to ICU till the day of discharge from ICU, up to six months
To investigate the effect of the systematic assessment of pain among patients groups - control and intervention as to the occurrence of adverse events
Time Frame: every 24 hrs for ten continuous days
every 24 hrs for ten continuous days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cyprus University of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nicosia General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Evanthia G Georgiou, PhD Cand, Cyprus University of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EX 043 - EP2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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