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).
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Candelas Lopez Lopez
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- To assess the construct validity and the reliability
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Candelas Lopez Lopez
RN, MSc, PhD
Hospital Universitario 12 de Octubre
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
To assess the construct validity and the reliability
Time Frame: 30 months
Number of patients with Brain Damage, non-communicative and artificial airway that manifest pain behaviors included in the Pain Indicator Behavior Scale-Brain Damage
Secondary Outcomes
- To analyze the scale under different levels of consciousness(30 months)
- To assess pain from different procedures with ESCID-DC scale(30 months)
- To assess pain from different procedures with NCS-R scale(30 months)
- To analyze the scale under different etiology of brain damage(30 months)
- To analyze the scale under different degrees of sedation(30 months)