Validation of "Escala de Conductas Indicadoras de Dolor" ESCID Scale for Measuring Pain in Critically Ill Patients
NCT ID: NCT01744717
Last Updated: 2016-09-19
Study Results
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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COMPLETED
286 participants
OBSERVATIONAL
2012-11-30
2016-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Critically ill uncommunicative patients
Critically ill non-communicative patients, on mechanical ventilation
Pain measurement
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:
* TURNING / POSITIONING (moving side to side or up or down in bed)
* ENDOTRACHEAL SUCTIONING (insertion of suction catheter into the endotracheal tube or tracheostomy in order to aspirate secretions)
* NON PAINFUL PROCEDURE (Soft friction with gauze cloth on a healthy skin tissue portion, in the outer arm, forearm or anterior tibial area)
Interventions
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Pain measurement
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:
* TURNING / POSITIONING (moving side to side or up or down in bed)
* ENDOTRACHEAL SUCTIONING (insertion of suction catheter into the endotracheal tube or tracheostomy in order to aspirate secretions)
* NON PAINFUL PROCEDURE (Soft friction with gauze cloth on a healthy skin tissue portion, in the outer arm, forearm or anterior tibial area)
Eligibility Criteria
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Inclusion Criteria
* Patient's primary language spanish where the evaluation is performed
* Patient meets IRB/Central EC requirements of the institution/ country where the evaluation is performed
* Patient is receiving the study's procedures as part of standard care, excepting the non painful procedure
Exclusion Criteria
* Patient is receiving neuromuscular blocking medications at the time of measurement of pain
* Patient´s probable or diagnosed delirium
18 Years
ALL
No
Sponsors
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Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
OTHER
Hospital Universitario Getafe
OTHER
Hospital Universitario 12 de Octubre
OTHER
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
Puerta de Hierro University Hospital
OTHER
Responsible Party
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Ignacio Latorre Marco
Nurse Degree, Intensive Care Unit nurse staff
Principal Investigators
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Ignacio Latorre, RN
Role: PRINCIPAL_INVESTIGATOR
Puerta de Hierro Majadahonda University Hospital. Medical ICU. Spain.
Locations
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Puerta de Hierro Majadahonda University Hospital. Intensive Care Unit.
Majadahonda, Madrid, Madrid, Spain
Countries
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References
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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.
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.
Other Identifiers
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ESCID-02
Identifier Type: -
Identifier Source: org_study_id
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