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临床试验/NCT02720731
NCT02720731Unknown不适用

Care-related Pain and Discomfort in Children and Adults With Motor Disorder in Medical Establishments

University Hospital, Brest10 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
10
主要终点
Pain related to care-activities assessed with the Face, Legs, Activity, Cry, Consolability (FLACC-r) scale

研究概览

简要总结

The combination of motor disabilities, chronic pain, cognitive disabilities limiting the possibilities of communications and repeated potentially painful rehabilitation, exposes patients with motor disabilities to a high risk of induced pain in the specialized establishments. Induced pain is difficult to detect and is therefore little assessed and treated. Currently, little is known about the prevalence and conditions of occurrence of such induced pain as the clinical characteristics of patients (children, adults, severity of disability), the types of care and the nature of the institutional admission (medical or medico-social). Secondary objectives are to identify risk factors related to the induced pain and patient characteristics, as well as to create an easy-to-use weekly continuous pain assessment tool in a routine clinical set-up.

All daily life procedures or treatment carried out in children and adults with motor disability are collected for 5 days and 1 night. Collected data are clinical and demographic characteristics of patients, the intensity of the pain assessed by the care professional (FLACC-r) or the patient himself (VAS).

Clinically, the uncomfortable and painful procedures and risk factors for pain identified by this study will help the development of targeted preventive measures within institutions. Meanwhile, the study should sensitize Breton teams involved with regards to the induced pain, leading them to observe the behavior of patients, to admit any pain related to an act of daily life, and to ask for the medical profession to anticipate the painful experience.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
1 Year 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • motor disorder
  • institutionalized

排除标准

  • chronical pain

结局指标

主要结局

Pain related to care-activities assessed with the Face, Legs, Activity, Cry, Consolability (FLACC-r) scale

时间窗: 5 days

次要结局

  • Pain related to care-activities assessed with the Visual Analog Scale (VAS).(5 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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