Validity and Reliability Study of the Pain Indicator Behavior Scale-Brain Damage (ESCID-DC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pain assessment using a behavioral scale.
- Who it may be relevant to
- Registry conditions: Pain, Brain Injuries, Behavior. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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).
Overview
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.
Interventions
- Other Pain assessment using a behavioral scale
The pain of the subjects will be evaluated by two independent observers and with a blind result between them, coinciding with the application of two painful procedures used in routine practice: suction of tracheal secretions and the pressure in the nail bed by means of a pressure algometer. In addition, a painless procedure will also be performed to establish an element of control with the procedures painful. This will consist of the application of gentle friction with a cloth gauze, on a part o
Primary outcome measures
- To assess the construct validity and the reliability [Time frame: 30 months]
Secondary outcome measures (5)
- To assess pain from different procedures with ESCID-DC scale [Time frame: 30 months]
- To assess pain from different procedures with NCS-R scale [Time frame: 30 months]
- To analyze the scale under different etiology of brain damage [Time frame: 30 months]
- To analyze the scale under different levels of consciousness [Time frame: 30 months]
- To analyze the scale under different degrees of sedation [Time frame: 30 months]
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.
- Level of deep sedation (RASS -5).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Emergency and Trauma Intensive Care Unit. Hospital Universitario 12 de Octubre — Madrid
Publications
- Lopez-Lopez C, Latorre-Marco I, Sanchez-Sanchez MDM, Sarabia-Cobo CM, Solis-Munoz M, Perez-Perez T, Roldan-Merino J, Robleda-Font G. Content Validation of the Behavioural Indicators of Pain Scale in Critically Ill Patients With Acquired Brain Injury: A Delphi Study. Nurs Crit Care. 2025 May;30(3):e70053. doi: 10.1111/nicc.70053. PMID 40417781
- Lopez-Lopez C, Latorre-Marco I, Perez-Perez T, Sarabia-Cobo CM, Solis-Munoz M, Sanchez-Sanchez MDM, Arranz-Esteban A, Frade-Mera MJ, Temprano-Vazquez S, Robleda-Font G. Validity and Reliability of the Behavioural Indicators of Pain Scale Adapted to Patients With Acquired Brain Injury: ESCID-DC Study Protocol. J Adv Nurs. 2025 Aug;81(8):5143-5150. doi: 10.1111/jan.16983. Epub 2025 Apr 18. PMID 40249752
Identifiers
NCT: NCT04898491 · ESCID-DC