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

Pain Clinical Trial

— ESCID-DC  

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04898491
• Other study ID #: ESCID-DC
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Hospital Universitario 12 de Octubre
• Contact: Candelas López-López, PhD
• Phone: +34 917792634
• Email: candelas.lopez[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Behavior
• Brain Injuries
• Pain

Intervention

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 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.

Locations

Country	Name	City	State
Spain	Emergency and Trauma Intensive Care Unit. Hospital Universitario 12 de Octubre	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Candelas Lopez Lopez	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the construct validity and the reliability	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	To assess pain from different procedures with ESCID-DC scale	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
Secondary	To assess pain from different procedures with NCS-R scale	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
Secondary	To analyze the scale under different etiology of brain damage	Pain score of patients with different etiology of brain damage (ischemic, traumatic and / or post-anoxic encephalopathy)	30 months
Secondary	To analyze the scale under different levels of consciousness	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
Secondary	To analyze the scale under different degrees of sedation	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