Clinical trial NCT04898491: Validity and Reliability Study of the Pain Indicator Behavior Scale-Brain Damage (ESCID-DC)
Official title: 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).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain
Brain Injuries
Behavior
Keywords: Pain
Brain injury
Brain damage
Intensive Critical Unit
Nursing
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2021-05-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age equal to or greater than 18 years.
2. Inability to communicate verbally or motor.
3. Have a artificial airway.
4. Informed consent of the family member or representative of the patient.

Exclusion Criteria:

1. Previous pathology of cognitive impairment.
2. Previous brain injury.
3. Previous psychiatric disorder.
4. Previous dementia.
5. Previous chronic substance abuse.
6. Previous chronic diabetics.
7. Previous spinal cord injury.
8. Previous severe polyneuropathy (diagnosed or suspected).
9. Confirmed diagnosis of brain death.
10. Continuous infusion of muscle relaxants and / or barbiturate coma.
11. Level of deep sedation (RASS -5).

Primary outcomes:
measure: To assess the construct validity and the reliability
timeFrame: 30 months
Secondary outcomes:
measure: To assess pain from different procedures with ESCID-DC scale
timeFrame: 30 months
measure: To assess pain from different procedures with NCS-R scale
timeFrame: 30 months
measure: To analyze the scale under different etiology of brain damage
timeFrame: 30 months
measure: To analyze the scale under different levels of consciousness
timeFrame: 30 months
measure: To analyze the scale under different degrees of sedation
timeFrame: 30 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Emergency and Trauma Intensive Care Unit. Hospital Universitario 12 de Octubre
Study officials:
affiliation: Emergency and Trauma Intensive Care Unit. Hospital Universitario 12 de Octubre
name: Candelas López-López, PhD
role: STUDY_CHAIR
References: