Impact of Music on Preoperative Anxiety Level Measured by Heart Rate Variability During Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 3
- 主要终点
- Comparison of heart rate variability before vs after listening to music in patients scheduled for cataract surgery under topical anesthesia.
研究概览
简要总结
The goal of this Randomized Controlled Trial is to evaluate heart rate variability (HRV)before and after listening to music in patients scheduled for cataract surgery under topical anesthesia, compared to patients who do not listen to music. Our hypothesis is that the anxious population with a low HRV benefits from an anxiolytic effect of music to increase HRV levels.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •information and consent of the patient,
- •age greater than or equal to 18 years,
- •affiliation to a social security system,
- •benefiting from non-emergency ambulatory cataract surgery under topical anesthesia
- •not being under legal protection.
排除标准
- •Refusal to participate,
- •language barriers that are incompatible with a reliable assessment
- •use of beta-blockers, including eye drops
- •use of adrenergic, antiadrenergic, cholinergic and anticholinergic drugs
- •use of psychotropic drugs, anxiolytics.
研究组 & 干预措施
Music Listening
The presentation of the music listening session will be standardized and will be as follows: "Make yourself comfortable; we will first choose the musical style; then adjust the volume; put on the headphones; then the mask; let us know if something is wrong; we can take off the headphones or the mask at any time if you wish; we will stay by your side".
The following data will be collected just before the headset is put on and just after its removal:
- heart rate using a previously disinfected chest belt (PolarH10®)
- blood pressure
- level of anxiety (according to the validated SFQ and VAS scales)
Music listening session will last 15 minutes, at the end of which the headphones will be removed before the patient is transferred to the operating room.
干预措施: Music listening (Other)
No Music
Heart rate variability monitoring while NOT listening to music. The presentation for the patients included in the group without music will be as follows: "Make yourself comfortable; we will first put on the headphones but there will be no music; let us know if anything is wrong; we can remove the headphones or mask at any time if you wish; we will stay by your side".
The following data will be collected just before the headset is put on and just after its removal:
- heart rate using a previously disinfected chest belt (PolarH10®)
- blood pressure
- level of anxiety (according to the validated SFQ and VAS scales)
The session will last 15 minutes, at the end of which the headphones will be removed before the patient is transferred to the operating room.
结局指标
主要结局
Comparison of heart rate variability before vs after listening to music in patients scheduled for cataract surgery under topical anesthesia.
时间窗: Baseline vs pre-surgery
Use of a non-invasive sensor: recording chest belt
次要结局
- Evaluation of the impact of music on the incidence of surgical complications(Immediately after the surgery)
- Measurement of subjective anxiety level(Before surgery)
研究者
Giuseppe Giannaccare
Professor
University of Cagliari