Validation of "Escala de Conductas Indicadoras de Dolor" ESCID Scale for Measuring Pain in Critically Ill Patients

Pain is an unpleasant and important stress factor, and a potentially harmful experience for critically ill patients. Pain is harder to evaluate in non-communicative patients, who can´t report their own pain. Behavioral indicators have been proved as useful and reliable for detecting and measuring pain in these patients, and have been the basis for constructing scales for measuring pain, such as the Behavioural Pain Scale (BPS), the Critical Care Observation Tool (CPOT) and the Scale of Behaviors Indicating Pain (ESCID) .

The BPS and ESCID were tested in a study with a sample of 42 critically ill patients in Spain, showing good validity and reliability.

The objective of this Spanish multicentre study is to test the validity and reliability of the ESCID scale in a large sample of critically ill patients with medical and postsurgical pathology for the detection and measurement of pain.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Puerta de Hierro Majadahonda University Hospital. Intensive Care Unit.

Majadahonda, Madrid, Madrid, 28222, Spain

About this study

The specific Aims for the study are :

To determine the validity and reliability of the ESCID scale to assess pain in non-communicative critically ill patients on mechanical ventilation, in a large sample of critically ill medical and surgical patients.

To assess the relationship between the application of a common and painful procedure, usual in daily practice, and its associated changes in physiological indicators of pain: variation of heart rate, blood pressure, respiratory rate, sweating.

To assess the degree of pain when applying two painful procedures documented as common in the usual care of critically ill patients, and one non-painful procedure, using two pain scales: ESCID and BPS.

To assess the differences in the employment of the pain scales in patients with medical and surgical pathology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient must be 18 years of age or older
Patient's primary language spanish where the evaluation is performed
Patient meets IRB/Central EC requirements of the institution/ country where the evaluation is performed
Patient is receiving the study's procedures as part of standard care, excepting the non painful procedure

Exclusion criteria

Patient's condition is very unstable at the time of measurement of pain
Patient is receiving neuromuscular blocking medications at the time of measurement of pain
Patient´s probable or diagnosed delirium

Treatment and study plan

Pain Measurement

Other

Pain intensity will be measured using 2 scales based on behaviour items, the Behavioural Pain Scale (BPS) and the ESCID scale (Escala de Conductas Indicadoras de Dolor), by two independent observers , when applying two procedures registered as painful (PD) and common in clinical practice, and a non-painful procedure (PND). The measurement will be performed once per each patient and procedure.

The procedures to be studied are the following:

TURNING / POSITIONING (moving side to side or up or down in bed)
ENDOTRACHEAL SUCTIONING (insertion of suction catheter into the endotracheal tube or tracheostomy in order to aspirate secretions)
NON PAINFUL PROCEDURE (Soft friction with gauze cloth on a healthy skin tissue portion, in the outer arm, forearm or anterior tibial area)

Primary outcomes

Pain intensity

Time frame: 20 minutes

Pain intensity will be measured through the use of 2 scales based on behaviour items, the Behavioural Pain Scale (BPS) and the ''Scale of Behavioral Indicators of Pain'' (ESCID-Escala de Conductas Indicadoras de Dolor), by two independent observers with blind result among them, when the application of two procedures registered as painful (PD) and common in clinical practice, mobilization and tracheal suctioning, and one non-painful procedure (PND). The measurement will be performed once per each patient and procedure. The measurement of pain will be carried out in 3 stages: 5 minutes before the PD/PND, during PD/PND and 15 minutes after PD/PND.

Sponsors and collaborators

Lead sponsor

Puerta de Hierro University Hospital

Other

Collaborators

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Hospital Galdakao-Usansolo
Hospital General Universitario Gregorio Marañon
Hospital San Carlos, Madrid
Hospital Universitario 12 de Octubre
Hospital Universitario Fundación Alcorcón
Hospital Universitario Getafe
Hospital Universitario Ramon y Cajal
Hospital Universitario de Fuenlabrada
Hospital de Basurto
Hospital de Cruces
Quirón Madrid University Hospital

Registry information

Official study title

"Estudio multicéntrico de Validez y Fiabilidad de la Escala de Conductas Indicadoras de Dolor ESCID Para Medir el Dolor en Pacientes críticos, no Comunicativos y Sometidos a ventilación mecánica"

Acronym: ESCID-MQ

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2016
First posted: Dec 7, 2012
Registry last updated: Sep 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed