Validity and Reliability Study of the Pain Indicator Behavior Scale-Brain Damage (ESCID-DC)
- Conditions
- Brain InjuriesBehaviorPain
- Registration Number
- NCT04898491
- Lead Sponsor
- Candelas Lopez Lopez
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the construct validity and the reliability 30 months Number of patients with Brain Damage, non-communicative and artificial airway that manifest pain behaviors included in the Pain Indicator Behavior Scale-Brain Damage
- Secondary Outcome Measures
Name Time Method To analyze the scale under different levels of consciousness 30 months 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)
To assess pain from different procedures with ESCID-DC scale 30 months 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)
To assess pain from different procedures with NCS-R scale 30 months 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)
To analyze the scale under different etiology of brain damage 30 months Pain score of patients with different etiology of brain damage (ischemic, traumatic and / or post-anoxic encephalopathy)
To analyze the scale under different degrees of sedation 30 months 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)
Trial Locations
- Locations (1)
Emergency and Trauma Intensive Care Unit. Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain