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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Other: Pain measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill uncommunicative patients<br>Critically ill non-communicative patients, on mechanical ventilation | Other: Pain measurement<br>* 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)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, mechanical ventilation, uncommunicative, Adult ICU patients pain