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

Stroke Clinical Trial

— ABBEY-F  

Official title:

Translation and Validation of the Abbey Pain Scale in Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04483141
• Other study ID #: RNI 2020 FERRIER
• Secondary ID: 2020-A01360-39
• Status: Recruiting
• Start date: May 10, 2021
• Est. completion date: June 2022

Study information

• Verified date: May 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: +33473754963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Stroke

Intervention

Diagnostic Test:
• Abbey Pain Scale
Hetero-assessment of pain

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Infrared pupillometry measurement	It is an absolute measurement of pupil size using a portable pupillometer	day 0 before treatment of acute pain
Secondary	Infrared pupillometry measurement	It is an absolute measurement of pupil size using a portable pupillometer	day 0 after treatment of acute pain