PainESCID-MQNCT01744717
Validation of "Escala de Conductas Indicadoras de Dolor" ESCID Scale for Measuring Pain in Critically Ill Patients
An observational study of Pain, run by Puerta de Hierro University Hospital at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Pain measurement
- How many people
- 286 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2012to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Puerta de Hierro Majadahonda University Hospital. Intensive Care Unit.
Majadahonda, Madrid, Madrid, 28222
About this study
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"
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Pain measurement
- Keywords
- Pain, mechanical ventilation, uncommunicative, Adult ICU patients pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Critically ill uncommunicative patients | Critically ill non-communicative patients, on mechanical ventilation Receives: Other: Pain measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación de Investigación Biomédica - 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, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Quirón Madrid University Hospital, Hospital de Cruces, Hospital de Basurto, Hospital Galdakao-Usansolo, Hospital Universitario Fundación Alcorcón, Hospital Universitario de Fuenlabrada
- Responsible party
- Principal investigator, Ignacio Latorre Marco, Puerta de Hierro University Hospital
- Investigators
- Ignacio Latorre, RN, Principal investigator, Puerta de Hierro Majadahonda University Hospital. Medical ICU. Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744717
- Sponsor's protocol ID
- ESCID-02
- Acronym
- ESCID-MQ
- Status last verified
- Sep 2016
- First submitted
- 14 Nov 2012
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26358885Latorre-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.
PubMed 27590592
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT01744717
- Acronym / sponsor ID
- ESCID-MQ / ESCID-02
- Conditions
- Pain
- Keywords
- Pain, mechanical ventilation, uncommunicative, Adult ICU patients pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Collaborators
- Fundación de Investigación Biomédica - 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, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Quirón Madrid University Hospital, Hospital de Cruces, Hospital de Basurto, Hospital Galdakao-Usansolo, Hospital Universitario Fundación Alcorcón, Hospital Universitario de Fuenlabrada
- Study start
- Nov 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill uncommunicative patients | – | Other: Pain measurementCritically ill non-communicative patients, on mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain measurementPain 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) | Other | Critically ill uncommunicative patients |
Primary outcome
Pain intensity
Time frame: 20 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- Background: PubMed 26358885Latorre-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.
- Results publication: PubMed 27590592Latorre-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ignacio Latorre, RN principal investigator
Puerta de Hierro Majadahonda University Hospital. Medical ICU. Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Puerta de Hierro University Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01744717, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.