Pain and Music Therapy During the Wound Healing in Patient Suffering Arteritis of Stage 5 or 6.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Pain relief during local care with music or not.
研究概览
简要总结
It is estimated that 800,000 people in France suffer from peripheral artery disease (PAD), of whom 1-2% present the most severe form critical limb ischaemia (CLI). In this situation, the patient frequently presents painful non-healing ulcers and focal gangrene. Wound care is generally associated with increasing pain. Pain relief may be challenging in spite of major analgesics.
Several studies in this country and elsewhere assessed the usefulness of music for chronic or acute pain relief during care. However, no data are published regarding the interest of music therapy for pain relief during local care in PAD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Men and women, aged at least 18 years, affiliated to the health insurance scheme.
- •Patients affected by arteritis of stage 5 or 6 at Limoges University Hospital in department cardiovascular Surgery.
- •Patients requiring a daily repair of bandage, not exceeding fifteen minutes and provoking a pain
- •Initial pain equal to three during local care in the digital scale.
- •Having given their enlightened consent writes
排除标准
- •Bypass and / or angioplasty lower than one week
- •Diabetic neuropathy
- •Patient who is going to undergo a surgery of amputation
- •Patients affected by demented pathologies or by confusion
- •Pregnant or breast-feeding women or without effective contraception
- •Patients being the object of a saving of justice
研究组 & 干预措施
control group
Coutrol group
干预措施: no music (Other)
Music therapy group
Local care with music
干预措施: Music (Other)
结局指标
主要结局
Pain relief during local care with music or not.
时间窗: 7 days
Different level of pain front-counterpart realization of the bandage which will be compared between both groups of patients in the seventh day after implementation of the procedure. The level of pain will be measured by a digital scale from 0 to 10.
次要结局
- Quantification in equivalent morphine of the analgesic prescription at the seventh day(7 days)