Translation and Validation of the Abbey Pain Scale in Stroke Patients (ABBEY-F)
Keywords
Abstract
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.
Dates
Last Verified: | 06/30/2020 |
First Submitted: | 07/19/2020 |
Estimated Enrollment Submitted: | 07/19/2020 |
First Posted: | 07/22/2020 |
Last Update Submitted: | 07/19/2020 |
Last Update Posted: | 07/22/2020 |
Actual Study Start Date: | 08/31/2020 |
Estimated Primary Completion Date: | 08/31/2021 |
Estimated Study Completion Date: | 09/30/2021 |
Condition or disease
Intervention/treatment
Diagnostic Test: Abbey Pain Scale
Phase
Arm Groups
Arm | 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). | |
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) |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Sampling method | Non-Probability Sample |
Accepts Healthy Volunteers | Yes |
Criteria | 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. |
Outcome
Primary Outcome Measures
1. Abbey Pain Hetero-Evaluation Scale [day 0]
Secondary Outcome Measures
1. Hospital Anxiety Depression Scale (HADS) Questionnaire [day 0]
2. Algoplus Pain Hetero-Evaluation Scale [day 0]
3. Numerical Scale [day 0]
4. Infrared pupillometry measurement [day 0 before treatment of acute pain]
5. Infrared pupillometry measurement [day 0 after treatment of acute pain]