Validity and Reliability Study of the Pain Indicator Behavior Scale-Brain Damage (ESCID-DC)

Study Overview
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Brief Summary
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A multicentre observational study to validate the adaptation of the Pain Indicator Behavior Scale (ESCID) for patients with acquired Brain Damage (ESCID-DC), as a measuring instrument.

Detailed Description
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Non-commercial study. The study complies with the ethical principles of the Declaration of Helsinki, the recommendations of Good Clinical Practice (GCP) and current legislation. The study has been approved with a favorable opinion by the CEIm of the Hospital Universitario 12 de Octubre. Written consent will be requested from the participants and / or their relatives / representatives to participate in the study.

Official Title
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Validity and Reliability Study of the Pain Indicator Behavior Scale Adapted to Measure Pain in Critically Ill Patients With Acquired Brain Damage, Non-communicative and With an Artificial Airway (ESCID-DC).

Conditions
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Pain, Brain Injuries, Behavior

Intervention / Treatment
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* Other: Pain assessment using a behavioral scale


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age equal to or greater than 18 years. Inability to communicate verbally or motor. Have a artificial airway. Informed consent of the family member or representative of the patient. Exclusion Criteria: Previous pathology of cognitive impairment. Previous brain injury. Previous psychiatric disorder. Previous dementia. Previous chronic substance abuse. Previous chronic diabetics. Previous spinal cord injury. Previous severe polyneuropathy (diagnosed or suspected). Confirmed diagnosis of brain death. Continuous infusion of muscle relaxants and / or barbiturate coma. Level of deep sedation (RASS -5).

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

| Intervention/Treatment |
| --- |
|Other: Pain assessment using a behavioral scale|The pain of the subjects will be evaluated by two independent observers and with a blind result between them, coinciding with the application of two painful procedures used in routine practice: suction of tracheal secretions and the pressure in the nail bed by means of a pressure algometer. In addition, a painless procedure will also be performed to establish an element of control with the procedures painful. This will consist of the application of gentle friction with a cloth gauze, on a part of healthy skin tissue of the patient. The measurement will be performed twice for each patient and procedure depending on the level of sedation, so that the first measurement will be performed with a deeper sedation level and the second with a change in sedation level to moderate-mild. In turn, the pain assessment will be carried out in three moments: first or baseline measurement, during the application of the painless and 15 minutes after finishing the procedures.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the construct validity and the reliability | Number of patients with Brain Damage, non-communicative and artificial airway that manifest pain behaviors included in the Pain Indicator Behavior Scale-Brain Damage | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess pain from different procedures with ESCID-DC scale | Pain score of patients before, during and after performing two procedures documented as painful (aspiration of tracheal secretions and application of pressure to the nail bed), common in the routine care of critically ill patients, and a procedure not painful (gentle friction with a cloth gauze on skin tissue) using the Indicator Behavior Scale of Pain in a Patient with Brain Damage (ESCID-DC) | 30 months | 
| To assess pain from different procedures with NCS-R scale | Pain score of patients before, during and after performing two procedures documented as painful (aspiration of tracheal secretions and application of pressure to the nail bed), common in the routine care of critically ill patients, and a procedure not painful (gentle friction with a cloth gauze on skin tissue) using the Nociception Coma Scale-Revised (NCS-R) | 30 months | 
| To analyze the scale under different etiology of brain damage | Pain score of patients with different etiology of brain damage (ischemic, traumatic and / or post-anoxic encephalopathy) | 30 months | 
| To analyze the scale under different levels of consciousness | Pain score of patients with different levels of consciousness (severe: Glasgow Coma Score <9 / moderate: Glasgow Coma Score 9-13 / mild: Glasgow Coma Score 14-15) | 30 months | 
| To analyze the scale under different degrees of sedation | Pain score of patients with different degrees of sedation (deep sedation: Richmond Agitation-Sedation Scale (RASS) Score -5, -4 / moderate sedation: Richmond Agitation-Sedation Scale (RASS) Score -3 and/or light sedation Richmond Agitation-Sedation Scale (RASS) Score -2, -1) | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Brain injury, Brain damage, Intensive Critical Unit, Nursing