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

"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"

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Pain measurement

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 286

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Majadahonda, Madrid, Madrid, Spain, 28222
      • Puerta de Hierro Majadahonda University Hospital. Intensive Care Unit.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ICU patients who are uncommunictive, receiving mechanical ventilation and undergoing any of the study procedures. Consent to participate will be requested to the family of the patient. Adults age 18 and over will be eligible for the study if they meet study inclusion criteria and don't meet any exclusion criteria.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Critically ill uncommunicative patients; Critically ill non-communicative patients, on mechanical ventilation

Other: Pain measurement; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	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.	20 minutes

Collaborators and Investigators

• Sponsor: Puerta de Hierro University Hospital
• Collaborators: Hospital General Universitario Gregorio Marañon; Hospital Universitario Ramon y Cajal; Hospital de Basurto; Hospital Universitario 12 de Octubre; Hospital San Carlos, Madrid; Fundación de Investigación Biomédica - Hospital Universitario de La Princesa; Hospital Universitario Getafe; Hospital Galdakao-Usansolo; Hospital Universitario Fundación Alcorcón; Quirón Madrid University Hospital; Hospital de Cruces; Hospital De la Santa Creu y Sant Pau; Hospital Universitario de Fuenlabrada
• Investigators: Principal Investigator: Ignacio Latorre, RN, Puerta de Hierro Majadahonda University Hospital. Medical ICU. Spain.

Publications and helpful links

General Publications

• Latorre-Marco I, Solis-Munoz M, Acevedo-Nuevo M, Hernandez-Sanchez ML, Lopez-Lopez C, Sanchez-Sanchez Mdel M, Wojtysiak-Wojcicka M, De las Pozas-Abril J. Validation of the Behavioural Indicators of Pain Scale ESCID for pain assessment in non-communicative and mechanically ventilated critically ill patients: a research protocol. J Adv Nurs. 2016 Jan;72(1):205-16. doi: 10.1111/jan.12808. Epub 2015 Sep 11.
• Latorre-Marco I, Acevedo-Nuevo M, Solis-Munoz M, Hernandez-Sanchez L, Lopez-Lopez C, Sanchez-Sanchez MM, Wojtysiak-Wojcicka M, de Las Pozas-Abril J, Robleda-Font G, Frade-Mera MJ, De Blas-Garcia R, Gorgolas-Ortiz C, De la Figuera-Bayon J, Cavia-Garcia C. Psychometric validation of the behavioral indicators of pain scale for the assessment of pain in mechanically ventilated and unable to self-report critical care patients. Med Intensiva. 2016 Nov;40(8):463-473. doi: 10.1016/j.medin.2016.06.004. Epub 2016 Aug 31. English, Spanish.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 14, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimate): December 7, 2012

Study Record Updates

• Last Update Posted (Estimate): September 19, 2016
• Last Update Submitted That Met QC Criteria: September 16, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: mechanical ventilation; Pain; uncommunicative; Adult ICU patients pain
• Other Study ID Numbers: ESCID-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided