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

Translation and Validation of the Abbey Pain Scale in Stroke Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Pain
• Intervention / Treatment: Diagnostic test: Abbey Pain Scale

Detailed Description

The study will be conducted over a 12-month period. 120 patients hospitalized for stroke including 60 communicating and 60 non-communicating patients will be recruited. Epidemiological data will be collected at enrollment, as well as an initial assessment using the Abbey and Algoplus scales for non-communicating and communicating patients, and also the numerical scale for communicating patients. The HADS questionnaire will be completed by communicating patients only. Of the 60 patients in each group, 30 will receive a second concurrent assessment by an inter-rater, 30 will receive a test/retest reassessment after 30 minutes, and 20 will be reassessed 90 minutes later by the same scales after pain treatment. For 30 of the 120 patients, an infrared pupillometry measurement will be performed before and after treatment of acute pain. All patients will be recruited from the neurovascular unit of the Clermont-Ferrand University Hospital.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Recruiting
    • CHU de Clermont-Ferrand
    • Principal Investigator: Anna FERRIER
    • Sub-Investigator: Nathalie BOURGEOIS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Hetero-assessment of pain
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; Hetero-assessment of pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety Depression Scale (HADS) Questionnaire	This scale is an instrument to screen for anxiety and depressive disorders. It consists of 14 items rated from 0 to 3. Seven questions relate to the anxiety dimension (total A) and seven others to the depressive dimension (total D), giving 2 scores. for communicant patients only	day 0
Algoplus Pain Hetero-Evaluation Scale	This scale searches for elements suggestive of pain in the patient by answering YES/NO to each of the items: face, gaze, complaints, body, and behaviour; score between 0 and 5.	day 0
Numerical Scale	This is a communicant patient's self-assessment of the intensity of pain felt, between 0 (no pain) and 10 (maximum pain). for communicant patients only	day 0
Infrared pupillometry measurement	It is an absolute measurement of pupil size using a portable pupillometer	day 0 before treatment of acute pain
Infrared pupillometry measurement	It is an absolute measurement of pupil size using a portable pupillometer	day 0 after treatment of acute pain

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Anna FERRIER, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: pain; stroke; aphasia; Abbey pain scale
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: RNI 2020 FERRIER; 2020-A01360-39 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No