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| Name | Class |
|---|---|
| Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | OTHER |
| Hospital Universitario Getafe | OTHER |
| Hospital Universitario 12 de Octubre | OTHER |
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Pain is an unpleasant and important stress factor, and a potentially harmful experience for critically ill patients. Pain is harder to evaluate in non-communicative patients, who can´t report their own pain. Behavioral indicators have been proved as useful and reliable for detecting and measuring pain in these patients, and have been the basis for constructing scales for measuring pain, such as the Behavioural Pain Scale (BPS), the Critical Care Observation Tool (CPOT) and the Scale of Behaviors Indicating Pain (ESCID) .
The BPS and ESCID were tested in a study with a sample of 42 critically ill patients in Spain, showing good validity and reliability.
The objective of this Spanish multicentre study is to test the validity and reliability of the ESCID scale in a large sample of critically ill patients with medical and postsurgical pathology for the detection and measurement of pain.
The specific Aims for the study are :
To determine the validity and reliability of the ESCID scale to assess pain in non-communicative critically ill patients on mechanical ventilation, in a large sample of critically ill medical and surgical patients.
To assess the relationship between the application of a common and painful procedure, usual in daily practice, and its associated changes in physiological indicators of pain: variation of heart rate, blood pressure, respiratory rate, sweating.
To assess the degree of pain when applying two painful procedures documented as common in the usual care of critically ill patients, and one non-painful procedure, using two pain scales: ESCID and BPS.
To assess the differences in the employment of the pain scales in patients with medical and surgical pathology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critically ill uncommunicative patients | Critically ill non-communicative patients, on mechanical ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain measurement | Other | Pain intensity will be measured using 2 scales based on behaviour items, the Behavioural Pain Scale (BPS) and the ESCID scale (Escala de Conductas Indicadoras de Dolor), by two independent observers , when applying two procedures registered as painful (PD) and common in clinical practice, and a non-painful procedure (PND). The measurement will be performed once per each patient and procedure. The procedures to be studied are the following:
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Pain intensity will be measured through the use of 2 scales based on behaviour items, the Behavioural Pain Scale (BPS) and the ''Scale of Behavioral Indicators of Pain'' (ESCID-Escala de Conductas Indicadoras de Dolor), by two independent observers with blind result among them, when the application of two procedures registered as painful (PD) and common in clinical practice, mobilization and tracheal suctioning, and one non-painful procedure (PND). The measurement will be performed once per each patient and procedure. The measurement of pain will be carried out in 3 stages: 5 minutes before the PD/PND, during PD/PND and 15 minutes after PD/PND. | 20 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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ICU patients who are uncommunictive, receiving mechanical ventilation and undergoing any of the study procedures. Consent to participate will be requested to the family of the patient. Adults age 18 and over will be eligible for the study if they meet study inclusion criteria and don't meet any exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Ignacio Latorre, RN | Puerta de Hierro Majadahonda University Hospital. Medical ICU. Spain. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Puerta de Hierro Majadahonda University Hospital. Intensive Care Unit. | Majadahonda, Madrid | Madrid | 28222 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26358885 | Background | Latorre-Marco I, Solis-Munoz M, Acevedo-Nuevo M, Hernandez-Sanchez ML, Lopez-Lopez C, Sanchez-Sanchez Mdel M, Wojtysiak-Wojcicka M, De las Pozas-Abril J. Validation of the Behavioural Indicators of Pain Scale ESCID for pain assessment in non-communicative and mechanically ventilated critically ill patients: a research protocol. J Adv Nurs. 2016 Jan;72(1):205-16. doi: 10.1111/jan.12808. Epub 2015 Sep 11. | |
| 27590592 |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Hospital Universitario Ramon y Cajal |
| OTHER |
| Hospital General Universitario Gregorio Marañon | OTHER |
| Hospital San Carlos, Madrid | OTHER |
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | OTHER |
| Quirón Madrid University Hospital | OTHER |
| Hospital de Cruces | OTHER |
| Hospital de Basurto | OTHER |
| Hospital Galdakao-Usansolo | OTHER_GOV |
| Hospital Universitario Fundación Alcorcón | OTHER |
| Hospital Universitario de Fuenlabrada | OTHER |
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| Result |
| Latorre-Marco I, Acevedo-Nuevo M, Solis-Munoz M, Hernandez-Sanchez L, Lopez-Lopez C, Sanchez-Sanchez MM, Wojtysiak-Wojcicka M, de Las Pozas-Abril J, Robleda-Font G, Frade-Mera MJ, De Blas-Garcia R, Gorgolas-Ortiz C, De la Figuera-Bayon J, Cavia-Garcia C. Psychometric validation of the behavioral indicators of pain scale for the assessment of pain in mechanically ventilated and unable to self-report critical care patients. Med Intensiva. 2016 Nov;40(8):463-473. doi: 10.1016/j.medin.2016.06.004. Epub 2016 Aug 31. English, Spanish. |