NCT01744717

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 7, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

Enrollment Period

3.1 years

First QC Date

November 14, 2012

Last Update Submit

September 16, 2016

Conditions

Pain

Keywords

Painmechanical ventilationuncommunicativeAdult ICU patients pain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Critically ill uncommunicative patients

Critically ill non-communicative patients, on mechanical ventilation

Other: Pain measurement

Interventions

Pain measurementOTHER

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)

Critically ill uncommunicative patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Puerta de Hierro Majadahonda University Hospital. Intensive Care Unit.

Majadahonda, Madrid, Madrid, 28222, Spain

Location

Related Publications (2)

  • 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.

    PMID: 26358885BACKGROUND

  • 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.

    PMID: 27590592RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ignacio Latorre, RN

    Puerta de Hierro Majadahonda University Hospital. Medical ICU. Spain.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Degree, Intensive Care Unit nurse staff

Study Record Dates

First Submitted

November 14, 2012

First Posted

December 7, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

September 19, 2016

Record last verified: 2016-09

Locations

ES(1)