NCT04898491

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

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).

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Candelas Lopez Lopez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Brain Injuries
• Behavior

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-12-31
• Completion: 2025-06-30
• First posted: 2021-05-24
• Last updated: 2025-04-02

Locations

1 site across 1 country: Spain