RESUMEN
AIM: To investigate the validity and reliability of the Behavioural Indicators of Pain Scale (ESCID) in medically and surgically non-communicative and mechanically ventilated critical patients. BACKGROUND: Scales based on behavioural indicators of pain are suggested to measure pain in non-communicative critically ill patients. Scales proposed thus far have a range not comparable to those used with patients who can report their pain. A scale with a 0-10 range and more behavioural indicators is proposed to improve the detection and measurement of pain. DESIGN: A multicentre prospective observational design to validate a scale-measuring instrument. METHODS: Three hundred non-communicative and mechanically ventilated critical patients from 20 different intensive care units will be observed for 5 minutes before, during and 15 minutes after three procedures: turning, tracheal suctioning and soft friction with gauze on healthy tissue. Two independent observers will assess the pain of subjects with the Behavioural Pain Scale and the ESCID scale simultaneously. Descriptive and inferential statistics will be used. Student's t-test will be used to compare components of the twos scales. Inter-rater and intrarater agreement will be investigated. The reliability scale will be measured using Cronbach's alpha. Approval date for this protocol was January 2012. DISCUSSION: A greater number of behavioural indicators in the ESCID scale than in previously validated scales, with a 0-10 score range, can improve the detection and measurement of pain in non-communicative and mechanically ventilated critical patients. Funding granted in 2011 by the Spanish Health Research Fund (PI 11/00766, Health Ministry). TRIAL REGISTRATION: Study registered with www.clinicaltrials.gov (NCT01744717).