NCT00193986已完成不适用
Assessment of Prepulse Inhibition for Shock Pain Reduction- Ventricular
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Assessment from pain perception from a shock preceded by a prepulse compared to a non prepulsed shock
研究概览
简要总结
Patient tolerance of pain from discharges of implantable cardioverter defibrillators (ICD's) is highly variable. It can be influenced by psychological factors, physical condition and the number of shocks delivered.
It has been shown that cutaneous pain perception can be reduced by delivery of a weak , low voltage pulse (prepulse)prior to the delivery of a stronger shock.
A prepulse delivered before a high voltage ICD shock will decrease discomfort compared to a shock of equal energy without a prepulse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18+ Approved indication for implantation of an ICD Able and willing to provide informed consent Independently complete and understand the Mini Mental State Evaluation
排除标准
- •Pregnancy Cannot understand English or French Contraindicated for defibrillation testing because of risk of thromboembolism Deaf or hard of hearing, making the acute testing difficult to conduct having pain or anxiety to the extent that, in the opinion of the investigator, the results would be confounded.
- •Having a Class I bradycardia pacing indication, requiring ongoing pacing support.
- •Visual problems which preclude reading the computer screen for the VAS test Severe musculoskeletal disorder that makes it difficult to undergo testing in the recumbent position Do not achieve a score >24/30 on a Mini Mental State Exam
结局指标
主要结局
Assessment from pain perception from a shock preceded by a prepulse compared to a non prepulsed shock
次要结局
未报告次要终点
研究者
研究点 (2)
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