Evaluation of Touch Massage on Anxiety in Critically Ill Patients : a Randomised Controlled Trial Study (REaLAX)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Measure the anxiolytic value of touch massage to critically ill patient, awake, communicating
研究概览
简要总结
Anxiety is a common problem encountered in a about 43 % of critically ill patients. Its occurrence can be related to several causes, mainly dominated by invasive procedures.
anxiety management is typically based on a combination of prevention, evaluation, and therapeutic agents. However, it appears important to develop adjuvant approaches. Touch massage is one of them and that has been evaluated in various medical conditions.
The aim of our study is to evaluate the anxiolytic effect of touch massage in critically ill patients during potentially painful nursing procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •All adult patients (age≥18 years) hospitalized in Intensive Care Unit > 24 h
- •Requiring mechanical ventilation or not
- •Securité Sociale affiliated
- •Patient with accessible zone for touch massage (head-face, arms-hands, feet, legs and back)
- •No significant event (invasive procedure, diagnostic ad, CAT,MRI) before enrollment
排除标准
- •Legal guardianship
- •Neurological failure : stroke ischemic or hemorrhagic, meningitis, status epilepticus,polytrauma( including head trauma),meningo encephalitis, meningism,
- •Patient with upper limbs neuromuscular disorders
- •Cutaneous lesion (zone of touch massage)
- •Temperature ≥ 38,5°C
- •A positive score of CAM ICU scale
- •Patient refuse to participate
结局指标
主要结局
Measure the anxiolytic value of touch massage to critically ill patient, awake, communicating
时间窗: 60 minutes
Total score variation of the Spielberger STAI Y-A anxiety scale (short form) before and after the touch massage session (score 6-24) or standard care ICU.
次要结局
- Measure the correlation between the Spielberger STAI Y-A (short form) anxiety scale and the Anxiety Visual Anxiety Scale (EVA-A).(60 minutes)
- Measure the analgesic effect of touch massage to critically ill patient awake, communicating(60 minutes)
研究者
Melot Karine
Study principal investigator
Versailles Hospital