Translation and Validation of the Abbey Pain Scale in Stroke Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Abbey Pain Hetero-Evaluation Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Refusal ;
- •Legally protected patient
- •Pregnancy;
- •Pre-stroke psychiatric or neurodevelopmental disorders;
- •Transient ischemic attack;
- •Specific strokes: Bithalamic, locked-in syndrome.
结局指标
主要结局
Abbey Pain Hetero-Evaluation Scale
时间窗: day 0
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.
次要结局
- Hospital Anxiety Depression Scale (HADS) Questionnaire(day 0)
- Algoplus Pain Hetero-Evaluation Scale(day 0)
- Infrared pupillometry measurement(day 0 after treatment of acute pain)
- Numerical Scale(day 0)