PainESCID-DCNCT04898491
Validity and Reliability Study of the Pain Indicator Behavior Scale-Brain Damage (ESCID-DC)
An observational study of Pain and Brain Injuries, run by Candelas Lopez Lopez at 1 site in Spain.
Trial summary
A multicentre observational study to validate the adaptation of the Pain Indicator Behavior Scale (ESCID) for patients with acquired Brain Damage (ESCID-DC), as a measuring instrument. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Brain Injuries, Behavior
- What is being tested?
- Pain assessment using a behavioral scale
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2022to 30 Jun 2025
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with acquired brain damage (ACD) admitted to the Intensive Critical Care (ICU) of the aforementioned hospitals, who comply with all the inclusion criteria and none of the exclusion criteria for the study.
Who may be able to join
- Age equal to or greater than 18 years.
- Inability to communicate verbally or motor.
- Have a artificial airway.
- Informed consent of the family member or representative of the patient.
Who cannot join
- Previous pathology of cognitive impairment.
- Previous brain injury.
- Previous psychiatric disorder.
- Previous dementia.
- Previous chronic substance abuse.
- Previous chronic diabetics.
Show all 11Show fewer
- Previous spinal cord injury.
- Previous severe polyneuropathy (diagnosed or suspected).
- Confirmed diagnosis of brain death.
- Continuous infusion of muscle relaxants and / or barbiturate coma.
- Level of deep sedation (RASS -5).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Emergency and Trauma Intensive Care Unit. Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Candelas López-López, PhD, candelas.lopez@salud.madrid.org
Santiago Pérez-García, sperezg@salud.madrid.org
About this study
Official title: Validity and Reliability Study of the Pain Indicator Behavior Scale Adapted to Measure Pain in Critically Ill Patients With Acquired Brain Damage, Non-communicative and With an Artificial Airway (ESCID-DC).
A multicentre observational study to validate the adaptation of the Pain Indicator Behavior Scale (ESCID) for patients with acquired Brain Damage (ESCID-DC), as a measuring instrument.
Read the detailed description
Non-commercial study. The study complies with the ethical principles of the Declaration of Helsinki, the recommendations of Good Clinical Practice (GCP) and current legislation.
The study has been approved with a favorable opinion by the CEIm of the Hospital Universitario 12 de Octubre.
Written consent will be requested from the participants and / or their relatives / representatives to participate in the study.
- Conditions
- Pain, Brain Injuries, Behavior
- Being tested
- Pain assessment using a behavioral scale
- Keywords
- Pain, Brain injury, Brain damage, Intensive Critical Unit, Nursing
- Medical subject headings
- Pain, Brain Injuries, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain assessment using a behavioral scaleOther
The pain of the subjects will be evaluated by two independent observers and with a blind result between them, coinciding with the application of two painful procedures used in routine practice: suction of tracheal secretions and the pressure in the nail bed by means of a pressure algometer. In addition, a painless procedure will also be performed to establish an element of control with the procedures painful. This will consist of the application of gentle friction with a cloth gauze, on a part of healthy skin tissue of the patient. The measurement will be performed twice for each patient and procedure depending on the level of sedation, so that the first measurement will be performed with a deeper sedation level and the second with a change in sedation level to moderate-mild.
In turn, the pain assessment will be carried out in three moments: first or baseline measurement, during the application of the painless and 15 minutes after finishing the procedures.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the construct validity and the reliability
Number of patients with Brain Damage, non-communicative and artificial airway that manifest pain behaviors included in the Pain Indicator Behavior Scale-Brain Damage
Measured: 30 months
Secondary outcomes (5)
To assess pain from different procedures with ESCID-DC scale
Pain score of patients before, during and after performing two procedures documented as painful (aspiration of tracheal secretions and application of pressure to the nail bed), common in the routine care of critically ill patients, and a procedure not painful (gentle friction with a cloth gauze on skin tissue) using the Indicator Behavior Scale of Pain in a Patient with Brain Damage (ESCID-DC)
Measured: 30 months
To assess pain from different procedures with NCS-R scale
Pain score of patients before, during and after performing two procedures documented as painful (aspiration of tracheal secretions and application of pressure to the nail bed), common in the routine care of critically ill patients, and a procedure not painful (gentle friction with a cloth gauze on skin tissue) using the Nociception Coma Scale-Revised (NCS-R)
Measured: 30 months
To analyze the scale under different etiology of brain damage
Pain score of patients with different etiology of brain damage (ischemic, traumatic and / or post-anoxic encephalopathy)
Measured: 30 months
To analyze the scale under different levels of consciousness
Pain score of patients with different levels of consciousness (severe: Glasgow Coma Score <9 / moderate: Glasgow Coma Score 9-13 / mild: Glasgow Coma Score 14-15)
Measured: 30 months
To analyze the scale under different degrees of sedation
Pain score of patients with different degrees of sedation (deep sedation: Richmond Agitation-Sedation Scale (RASS) Score -5, -4 / moderate sedation: Richmond Agitation-Sedation Scale (RASS) Score -3 and/or light sedation Richmond Agitation-Sedation Scale (RASS) Score -2, -1)
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Jun 2022
- Primary completion31 Dec 2023
- Study completion30 Jun 2025 (estimated)
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
- 300 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Candelas Lopez Lopez
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor-investigator, Candelas Lopez Lopez, Hospital Universitario 12 de Octubre
- Investigators
- Candelas López-López, PhD, Study chair, Emergency and Trauma Intensive Care Unit. Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898491
- Sponsor's protocol ID
- ESCID-DC
- Acronym
- ESCID-DC
- Status last verified
- Mar 2025
- First submitted
- 11 May 2021
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopez-Lopez C, Latorre-Marco I, Sanchez-Sanchez MDM, Sarabia-Cobo CM, Solis-Munoz M, Perez-Perez T, Roldan-Merino J, Robleda-Font G. Content Validation of the Behavioural Indicators of Pain Scale in Critically Ill Patients With Acquired Brain Injury: A Delphi Study. Nurs Crit Care. 2025 May;30(3):e70053. doi: 10.1111/nicc.70053.
PubMed 40417781Lopez-Lopez C, Latorre-Marco I, Perez-Perez T, Sarabia-Cobo CM, Solis-Munoz M, Sanchez-Sanchez MDM, Arranz-Esteban A, Frade-Mera MJ, Temprano-Vazquez S, Robleda-Font G. Validity and Reliability of the Behavioural Indicators of Pain Scale Adapted to Patients With Acquired Brain Injury: ESCID-DC Study Protocol. J Adv Nurs. 2025 Aug;81(8):5143-5150. doi: 10.1111/jan.16983. Epub 2025 Apr 18.
PubMed 40249752
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability Study of the Pain Indicator Behavior Scale Adapted to Measure Pain in Critically Ill Patients With Acquired Brain Damage, Non-communicative and With an Artificial Airway (ESCID-DC).
- ClinicalTrials.gov ID
- NCT04898491
- Acronym / sponsor ID
- ESCID-DC / ESCID-DC
- Conditions
- Pain, Brain Injuries, Behavior
- Keywords
- Pain, Brain injury, Brain damage, Intensive Critical Unit, Nursing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Candelas Lopez LopezUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 24 May 2021 (actual)
- 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.
A multicentre observational study to validate the adaptation of the Pain Indicator Behavior Scale (ESCID) for patients with acquired Brain Damage (ESCID-DC), as a measuring instrument.
Detailed description
Non-commercial study. The study complies with the ethical principles of the Declaration of Helsinki, the recommendations of Good Clinical Practice (GCP) and current legislation.
The study has been approved with a favorable opinion by the CEIm of the Hospital Universitario 12 de Octubre.
Written consent will be requested from the participants and / or their relatives / representatives to participate in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acquired brain damage (ACD) admitted to the Intensive Critical Care (ICU) of the aforementioned hospitals, who comply with all the inclusion criteria and none of the exclusion criteria for the study.
Key inclusion criteria (4 listed)
- Age equal to or greater than 18 years.
- Inability to communicate verbally or motor.
- Have a artificial airway.
- Informed consent of the family member or representative of the patient.
Key exclusion criteria (11 listed)
- Previous pathology of cognitive impairment.
- Previous brain injury.
- Previous psychiatric disorder.
- Previous dementia.
- Previous chronic substance abuse.
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 assessment using a behavioral scaleThe pain of the subjects will be evaluated by two independent observers and with a blind result between them, coinciding with the application of two painful procedures used in routine practice: suction of tracheal secretions and the pressure in the nail bed by means of a pressure algometer. In addition, a painless procedure will also be performed to establish an element of control with the procedures painful. This will consist of the application of gentle friction with a cloth gauze, on a part of healthy skin tissue of the patient. The measurement will be performed twice for each patient and procedure depending on the level of sedation, so that the first measurement will be performed with a deeper sedation level and the second with a change in sedation level to moderate-mild. In turn, the pain assessment will be carried out in three moments: first or baseline measurement, during the application of the painless and 15 minutes after finishing the procedures. | Other | – |
Primary outcome
To assess the construct validity and the reliability
Time frame: 30 months
Number of patients with Brain Damage, non-communicative and artificial airway that manifest pain behaviors included in the Pain Indicator Behavior Scale-Brain Damage
5 secondary outcomes
To assess pain from different procedures with ESCID-DC scale
Time frame: 30 months
To assess pain from different procedures with NCS-R scale
Time frame: 30 months
To analyze the scale under different etiology of brain damage
Time frame: 30 months
To analyze the scale under different levels of consciousness
Time frame: 30 months
To analyze the scale under different degrees of sedation
Time frame: 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 40417781Lopez-Lopez C, Latorre-Marco I, Sanchez-Sanchez MDM, Sarabia-Cobo CM, Solis-Munoz M, Perez-Perez T, Roldan-Merino J, Robleda-Font G. Content Validation of the Behavioural Indicators of Pain Scale in Critically Ill Patients With Acquired Brain Injury: A Delphi Study. Nurs Crit Care. 2025 May;30(3):e70053. doi: 10.1111/nicc.70053.
- Derived from this study: PubMed 40249752Lopez-Lopez C, Latorre-Marco I, Perez-Perez T, Sarabia-Cobo CM, Solis-Munoz M, Sanchez-Sanchez MDM, Arranz-Esteban A, Frade-Mera MJ, Temprano-Vazquez S, Robleda-Font G. Validity and Reliability of the Behavioural Indicators of Pain Scale Adapted to Patients With Acquired Brain Injury: ESCID-DC Study Protocol. J Adv Nurs. 2025 Aug;81(8):5143-5150. doi: 10.1111/jan.16983. Epub 2025 Apr 18.
- Individual participant dataSharing planned: No
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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.
Candelas López-López, PhD study chair
Emergency and Trauma Intensive Care Unit. Hospital Universitario 12 de Octubre
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 and Brain Injuries, run by Candelas Lopez Lopez 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 11 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: looking for participants now, as of the sponsor's last update on 2 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Candelas López-López, PhD (+34 917792634, candelas.lopez@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the construct validity and the reliability (time frame: 30 months). 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 NCT04898491, 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 2 Apr 2025.