RecruitingNCT04898491

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

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).


Sponsor

Candelas Lopez Lopez

Enrollment

300 participants

Start Date

Jun 1, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria11

  • 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).

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Interventions

OTHERPain 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.


Locations(1)

Emergency and Trauma Intensive Care Unit. Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

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