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

Candelas Lopez Lopez

Status: Enrolling

Conditions: Behavior; Brain Injuries; Pain

Treatments: Other: Pain assessment using a behavioral scale

Study type: Observational

Funder types: Other

Identifiers

NCT04898491

ESCID-DC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).