Validation of a pain assessment scale for patients with brain damage
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).
This study is testing a new way to measure pain in patients with brain damage who can’t speak or move, to help caregivers understand their pain better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario 12 de Octubre Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT04898491 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to validate the Pain Indicator Behavior Scale adapted for patients with acquired brain damage, known as ESCID-DC. The study will assess pain levels in patients who are unable to communicate verbally or motorically, using a behavioral scale. It adheres to ethical principles and Good Clinical Practice guidelines, with informed consent obtained from family members or representatives. The study is conducted in an intensive care unit setting, focusing on the unique challenges of assessing pain in critically ill patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with acquired brain damage who cannot communicate verbally or motorically.
Not a fit: Patients with previous cognitive impairments, brain injuries, or severe sedation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve pain assessment and management for patients with brain injuries, leading to better patient outcomes.
How similar studies have performed: Other studies have shown success in validating behavioral pain assessment tools in similar patient populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Madrid, Madrid
- Emergency and Trauma Intensive Care Unit. Hospital Universitario 12 de Octubre — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Candelas López-López, PhD
- Email: candelas.lopez@salud.madrid.org
- Phone: +34 917792634
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.