Validation of "Escala de Conductas Indicadoras de Dolor" ESCID Scale for Measuring Pain in Critically Ill Patients

Pain Clinical Trial

— ESCID-MQ  

Official title:

"Estudio multicéntrico de Validez y Fiabilidad de la Escala de Conductas Indicadoras de Dolor ESCID Para Medir el Dolor en Pacientes críticos, no Comunicativos y Sometidos a ventilación mecánica"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744717
• Other study ID #: ESCID-02
• Status: Completed
• Phase: N/A
• First received: November 14, 2012
• Last updated: September 16, 2016
• Start date: November 2012
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Puerta de Hierro University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient must be 18 years of age or older

• 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's condition is very unstable at the time of measurement of pain

• Patient is receiving neuromuscular blocking medications at the time of measurement of pain

• Patient´s probable or diagnosed delirium

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• 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)

Locations

Country	Name	City	State
Spain	Puerta de Hierro Majadahonda University Hospital. Intensive Care Unit.	Majadahonda, Madrid	Madrid

Sponsors (14)

Lead Sponsor

Collaborator

Puerta de Hierro University Hospital

Hospital de Basurto, Hospital de Cruces, Hospital De la Santa Creu y Sant Pau, Hospital Galdakao-Usansolo, Hospital General Universitario Gregorio Marañon, Hospital San Carlos, Madrid, Hospital Universitario 12 de Octubre, Hospital Universitario de Fuenlabrada, Hospital Universitario de la Princesa, Hospital Universitario Fundación Alcorcón, Hospital Universitario Getafe, Hospital Universitario Ramon y Cajal, Quirón Madrid University Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Latorre-Marco I, Acevedo-Nuevo M, Solís-Muñoz M, Hernández-Sánchez L, López-López C, Sánchez-Sánchez MM, Wojtysiak-Wojcicka M, de Las Pozas-Abril J, Robleda-Font G, Frade-Mera MJ, De Blas-García R, Górgolas-Ortiz C, De la Figuera-Bayón J, Cavia-García C. — View Citation

Latorre-Marco I, Solís-Muñoz M, Acevedo-Nuevo M, Hernández-Sánchez ML, López-López C, Sánchez-Sánchez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No