Translation and Validation of the Abbey Pain Scale in Stroke Patients (ABBEY-F)

NCT04483141 | Unknown

• 2 other identifiers: RNI 2020 FERRIER2020-A01360-39
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Pain is common after a stroke, affecting up to 49% of patients within 2 years of the event. They include headache, musculoskeletal pain, spasticity and central neuropathic pain. A wide range of patients have communication problems after stroke that make it difficult to assess pain. Yet there is a major impact of pain on the quality of life of these patients. Some tools have been validated to assess pain in non-communicative patients, but none are specific to stroke patients. The Algoplus scale is commonly used in intra-hospital care in France. The Abbey Pain Scale is not translated into French, and could provide a more accurate pain rating for non-communicative patients. The objective is to validate a French version of the Abbey Pain Scale for stroke patients. It is an observational study with longitudinal data collection. It is planned to include 120 patients from the neurology department of the Clermont-Ferrand University Hospital.

Conditions

Stroke; Pain

Keywords

stroke; pain; aphasia; Abbey pain scale

Outcome Measures

Primary Outcomes (1)

• Abbey Pain Hetero-Evaluation Scale

  This scale searches for elements suggestive of pain in the patient by scoring between 0 (absent) and 3 (severe) each of the items: vocalization, facial expression, body language, physiological modifications, physical modifications; obtaining a score between 0 and 18.

  day 0

Secondary Outcomes (5)

• Hospital Anxiety Depression Scale (HADS) Questionnaire

  day 0

• Algoplus Pain Hetero-Evaluation Scale

  day 0

• Numerical Scale

  day 0

• Infrared pupillometry measurement

  day 0 before treatment of acute pain

• Infrared pupillometry measurement

  day 0 after treatment of acute pain

Study Arms (2)

non-communicant stroke patients

Patients suffering from stroke, and unable to efficient communication. They will be assessed for pain through several tools (hetero-assessment of pain).

Diagnostic Test: Abbey Pain Scale

communicant stroke patients

Patients suffering from stroke, and unable to efficient communication. They will be assessed for pain through several tools (including hetero-assessment and auto-assessment of pain)

Diagnostic Test: Abbey Pain Scale

Interventions

Abbey Pain Scale DIAGNOSTIC_TEST

Hetero-assessment of pain

communicant stroke patients; non-communicant stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients hospitalized in the Neurovascular Unit for the management of ischemic stroke with or without reperfusion treatment, or hemorrhagic stroke

You may qualify if:

• at least 18 years old ;
• Covered by Social Security;
• Hospitalized in the Neurovascular Unit for the management of ischemic stroke with or without reperfusion treatment, or hemorrhagic stroke;
• NIHSS score greater than 1;
• For communicating patients: French mother tongue, or reading French without assistance, and able to understand the objectives.

You may not qualify if:

• Refusal ;
• Legally protected patient
• Pregnancy;
• Pre-stroke psychiatric or neurodevelopmental disorders;
• Transient ischemic attack;
• Specific strokes: Bithalamic, locked-in syndrome.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Stroke; Pain; Aphasia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations

Study Officials

• Anna FERRIER

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: May 10, 2021
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

FR (1)