Impact of Music Therapy on Intraoperative Patient Comfort During Cataract Surgery With Topic Anesthesia
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 主要终点
- Self-assessed anxiety score between the 2 groups
研究概览
简要总结
Cataract surgery with topic anesthesia is anxiety provoking. This operative stress can increase pain perception and blood pressure. This discomfort can lead to non-compliance with immobility and potentially lead to intraoperative and postoperative complications.
Pharmacological means are limited to reduce anxiety. Only anxiolytics could be effective but at the cost of side effects not compatible with surgery.
Music Care is a "digital treatment" allowing the diffusion of music with a U-shaped sequence using the principles of hypnoanalgesia.
The objective of this study is to evaluate the effectiveness of the MusicCare listening device on the anxiety of patients during cataract surgery with topic anesthesia
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
- Single (Investigator)
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
- •Cataract surgery with topical anesthesia
排除标准
- •Hearing impaired patient
结局指标
主要结局
Self-assessed anxiety score between the 2 groups
时间窗: Baseline day, when entering the operating room
Self-assessed anxiety score on a visual analogue scale (VAS) from 0 to 10 (0 means no anxiety and 10 the maximum anxiety)
次要结局
- Self-assessment of the duration of the surgery(Baseline day, when entering the operating room)
研究者
Benjamin Javillier
Principal Investigator
University of Liege