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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-06-30

Brief Summary

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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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Detailed Description

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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

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Pain Brain Injuries Behavior

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No