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临床试验/NCT04172662
NCT04172662已完成不适用

Music Therapy as an Adjunct in Cardiac Implantable Electronic Device (CIED) Lead Extraction Procedures

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2018年3月1日最近更新:
适应症

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

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

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sigrun Halvorsen

Professor MD PhD

Oslo University Hospital

研究点 (1)

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