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

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

COMPLETED

Total Enrollment

286 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Critically ill uncommunicative patients

Critically ill non-communicative patients, on mechanical ventilation

Pain measurement

Intervention Type 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:

* 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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

OTHER

Sponsor Role collaborator

Hospital Universitario Getafe

OTHER

Sponsor Role collaborator

Hospital Universitario 12 de Octubre

OTHER

Sponsor Role collaborator

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role collaborator

Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role collaborator

Hospital San Carlos, Madrid

OTHER

Sponsor Role collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role collaborator

Quirón Madrid University Hospital

OTHER

Sponsor Role collaborator

Hospital de Cruces

OTHER

Sponsor Role collaborator

Hospital de Basurto

OTHER

Sponsor Role collaborator

Hospital Galdakao-Usansolo

OTHER_GOV

Sponsor Role collaborator

Hospital Universitario Fundación Alcorcón

OTHER

Sponsor Role collaborator

Hospital Universitario de Fuenlabrada

OTHER

Sponsor Role collaborator

Puerta de Hierro University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ignacio Latorre Marco

Nurse Degree, Intensive Care Unit nurse staff

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Spain

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.

Reference Type BACKGROUND
PMID: 26358885 (View on PubMed)

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.

Reference Type RESULT
PMID: 27590592 (View on PubMed)

Other Identifiers

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ESCID-02

Identifier Type: -

Identifier Source: org_study_id

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