Status:
RECRUITING
Validity and Reliability Study of the Pain Indicator Behavior Scale-Brain Damage (ESCID-DC)
Lead Sponsor:
Candelas Lopez Lopez
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Pain
Brain Injuries
Eligibility:
All Genders
18+ years
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 ap...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04898491
Start Date
June 1 2022
End Date
June 30 2025
Last Update
April 2 2025
Active Locations (1)
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1
Emergency and Trauma Intensive Care Unit. Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain, 28041