Music Therapy as an Adjunct in Cardiac Implantable Electronic Device (CIED) Lead Extraction Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Patient experience of pain intensity during the procedure
研究概览
简要总结
The study will investigate possible effects of music therapy as an adjunct in an invasive cardiac procedure where infected or broken pacemaker leads, or leads from implantable cardioverter-defibrillators are removed from inside the heart through the vein. The procedure is performed in local anaesthesia with the patient awake. Analgesic and anxiolytic drugs are given at the start of the procedure, and repeated if needed. In spite of the drugs, most patients will experience som degree of pain and/or anxiety and increased stress during the procedure. The music therapy intervention contains individually facilitated music listening and coping techniques, aiming to regulate stress responses. The music listening and guidance is provided by a certified music therapist before, during and after the invasive procedure.
详细描述
See study protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned pacemaker or intracardiac defibrillator (ICD) lead extraction performed in local anaesthesia.
- •Lead implanted > 12 months ago
- •Able to speak and read Norwegian
- •Willing to participate All inclusion criteria must be fulfilled.
排除标准
- •Significant hearing impairment
- •Previous and/or acute psychiatric diagnosis
- •Cognitive and mental deficits or impaired functioning
结局指标
主要结局
Patient experience of pain intensity during the procedure
时间窗: Mean pain intensity during the procedure
Numeric Rating Scale (NRS, 0-10)
Patient satisfaction with pain management during the procedure
时间窗: 1 hour after completion of the procedure
10-point visual numeric scale, previously used in comparable studies. One represented very dissatisfied and 10 very satisfied
次要结局
- Patient experience of anxiety level during the procedure(Mean anxiety level during the procedure)
- Effect on vital sign(Mean arterial blood pressure during the procedure)
- Consumption of analgetic drugs during the procedure(Total amount of analgesic drug (fentanyl) given throughout the procedure)
研究者
Sigrun Halvorsen
Professor MD PhD
Oslo University Hospital
