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

Completed

• Conditions: Pain
• Interventions: Other: Pain measurement

• Registration Number: NCT01744717
• Lead Sponsor: Puerta de Hierro University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-07
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-16
• Last Update Posted: 2016-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critically ill uncommunicative patients	Pain measurement	Critically ill non-communicative patients, on mechanical ventilation

Primary Outcome Measures

Name	Time	Method
Pain intensity	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.

Trial Locations

Locations (1)

Puerta de Hierro Majadahonda University Hospital. Intensive Care Unit.; 🇪🇸 Majadahonda, Madrid, Madrid, Spain