Validation of the Critical-Care Pain Observation Tool (CPOT) in the Greek Population

NCT ID: NCT03654443

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2021-01-01

Brief 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. 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.

Conditions

Pain; Intensive Care Units

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Group Painful stimulus

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)

Group Type: EXPERIMENTAL

Critical care pain observation tool

Intervention Type: DIAGNOSTIC_TEST

The CPOT tool is administered in a crossover manner by two study observers

Group Non-painful stimulus

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)

Group Type: EXPERIMENTAL

Critical care pain observation tool

Intervention Type: DIAGNOSTIC_TEST

The CPOT tool is administered in a crossover manner by two study observers

Interventions

Critical care pain observation tool

The CPOT tool is administered in a crossover manner by two study observers

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients admitted in the ICU
• Age> 18 years old
• No hearing or visual deficit
• No contraindication to body repositioning

Exclusion Criteria

• Patients with neurological deficit
• Patients administered with neuromuscular blocking agents
• Patients with motor or sensory deficits

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint Savvas Anticancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Georgia Micha

Principal Investigator, Anaesthesiologist, MD, MSc, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgia Micha, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Saint Savvas Anticancer Hospital of Athens

Locations

Saint Savvas Anticancer Hospital of Athens

Athens, , Greece

Countries

Greece

References

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.

Reference Type: BACKGROUND

PMID: 19032510 (View on PubMed)

Kanji 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.

Reference Type: BACKGROUND

PMID: 26783859 (View on PubMed)

Other Identifiers

StSavvasAH

Identifier Type: -

Identifier Source: org_study_id