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NCT Number: NCT04898491

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

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.

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Key information

Conditions

Pain Behavior Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency and Trauma Intensive Care Unit. Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location status: Recruiting

Location contact

Candelas López-López, PhD

CONTACT

[email protected]

Santiago Pérez-García

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Pain assessment using a behavioral scale

Other

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 of healthy skin tissue of the patient. The measurement will be performed twice for each patient and procedure depending on the level of sedation, so that the first measurement will be performed with a deeper sedation level and the second with a change in sedation level to moderate-mild.

In turn, the pain assessment will be carried out in three moments: first or baseline measurement, during the application of the painless and 15 minutes after finishing the procedures.

Primary outcomes

  1. 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

  1. To assess pain from different procedures with ESCID-DC scale

    Time frame: 30 months

    Pain score of patients before, during and after performing two procedures documented as painful (aspiration of tracheal secretions and application of pressure to the nail bed), common in the routine care of critically ill patients, and a procedure not painful (gentle friction with a cloth gauze on skin tissue) using the Indicator Behavior Scale of Pain in a Patient with Brain Damage (ESCID-DC)

  2. To assess pain from different procedures with NCS-R scale

    Time frame: 30 months

    Pain score of patients before, during and after performing two procedures documented as painful (aspiration of tracheal secretions and application of pressure to the nail bed), common in the routine care of critically ill patients, and a procedure not painful (gentle friction with a cloth gauze on skin tissue) using the Nociception Coma Scale-Revised (NCS-R)

  3. To analyze the scale under different etiology of brain damage

    Time frame: 30 months

    Pain score of patients with different etiology of brain damage (ischemic, traumatic and / or post-anoxic encephalopathy)

  4. To analyze the scale under different levels of consciousness

    Time frame: 30 months

    Pain score of patients with different levels of consciousness (severe: Glasgow Coma Score <9 / moderate: Glasgow Coma Score 9-13 / mild: Glasgow Coma Score 14-15)

  5. To analyze the scale under different degrees of sedation

    Time frame: 30 months

    Pain score of patients with different degrees of sedation (deep sedation: Richmond Agitation-Sedation Scale (RASS) Score -5, -4 / moderate sedation: Richmond Agitation-Sedation Scale (RASS) Score -3 and/or light sedation Richmond Agitation-Sedation Scale (RASS) Score -2, -1)

Study contacts

Contact information is provided by the study sponsor or research team.

Candelas López-López, PhD

CONTACT

[email protected]

+34 917792634

Santiago Pérez-García, PhD

CONTACT

[email protected]

+34 917792689

Sponsors and collaborators

Lead sponsor

Candelas Lopez Lopez

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study 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).

Acronym: ESCID-DC

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
May 24, 2021
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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