About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Previous pathology of cognitive impairment.

Previous brain injury.

Previous psychiatric disorder.

Previous dementia.

Trial population

Patients with acquired brain damage (ACD) admitted to the Intensive Critical Care (ICU) of the aforementioned hospitals, who comply with all the inclusion criteria and none of the exclusion criteria for the study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Pain assessment using a behavioral scale
Other intervention
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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame

30 months

Secondary outcomes

1

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)

Time frame

30 months

2

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)

Time frame

30 months

3

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)

Time frame

30 months

4

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)

Time frame

30 months

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial population

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts