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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Hospital Universitario de la Princesa
Hospital Universitario Getafe
Hospital Universitario 12 de Octubre
Hospital Universitario Ramon y Cajal
Hospital General Universitario Gregorio Marañon
Hospital San Carlos, Madrid
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Hospital Universitario Quirón, Madrid, Spain
Hospital de Cruces
Hospital Universitario de Basurto
Hospital Galdakao-Usansolo
Hospital Universitario Fundación Alcorcón
Hospital Universitario de Fuenlabrada
Information provided by (Responsible Party):
Ignacio Latorre Marco, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier:
NCT01744717
First received: November 14, 2012
Last updated: March 2, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Pain
Other: Pain measurement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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"

Further study details as provided by Puerta de Hierro University Hospital:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Critically ill uncommunicative patients
Critically ill non-communicative patients, on mechanical ventilation
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)

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744717

Locations
Spain
Puerta de Hierro Majadahonda University Hospital
Majadahonda, Madrid, Madrid, Spain, 28222
Sponsors and Collaborators
Puerta de Hierro University Hospital
Hospital Universitario de la Princesa
Hospital Universitario Getafe
Hospital Universitario 12 de Octubre
Hospital Universitario Ramon y Cajal
Hospital General Universitario Gregorio Marañon
Hospital San Carlos, Madrid
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Hospital Universitario Quirón, Madrid, Spain
Hospital de Cruces
Hospital Universitario de Basurto
Hospital Galdakao-Usansolo
Hospital Universitario Fundación Alcorcón
Hospital Universitario de Fuenlabrada
Investigators
Principal Investigator: Ignacio Latorre, RN Puerta de Hierro Majadahonda University Hospital. Medical ICU. Spain.
  More Information

No publications provided

Responsible Party: Ignacio Latorre Marco, Nurse Degree, Intensive Care Unit nurse staff, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT01744717     History of Changes
Other Study ID Numbers: ESCID-02
Study First Received: November 14, 2012
Last Updated: March 2, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Puerta de Hierro University Hospital:
Pain
mechanical ventilation
uncommunicative
Adult ICU patients pain

ClinicalTrials.gov processed this record on November 20, 2014