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

March 28, 2025 updated by: Candelas Lopez Lopez

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).

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acquired brain damage (ACD) admitted to the Intensive Critical Care (ICU) of the aforementioned hospitals, who comply with all the inclusion criteria and none of the exclusion criteria for the study.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 months
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)
30 months
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)
30 months
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)
30 months
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)
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Candelas Lopez Lopez

Collaborators

Instituto de Salud Carlos III

Investigators

  • Study Chair: Candelas López-López, PhD, Emergency and Trauma Intensive Care Unit. Hospital Universitario 12 de Octubre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESCID-DC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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