The Effects of Music on Perioperative Outcomes in Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 4
- 主要终点
- Salivary Cortisol
研究概览
简要总结
The hypothesis of this trial is that listening to music will decrease the stress levels that patients face as evidenced by their STAI scores, salivary cortisol levels and intra-operative autonomic parameters.
详细描述
This randomized control trial was conducted from May- July 2014 across National University Hospital and Singapore National Eye Centre. All the patients of 10 consultants and senior consults and X medical officers were included in the study. A total of 148 participants were surveyed, and a total of X saliva samples were collected.
The inclusion criterion for patients was cataract surgery patients aged 50 years and above, with an acceptable hearing level based on CALFRAST hearing and the ability to wear clip-on on-ear headphones without discomfort. They were required to be mentally and physically capable of informed consent. Patients were also required to be ASA Grade 3 or lower.
Inclusion criterion for surgeons was surgeons doing phacoemulsification cataract surgeries, and for anaesthetists, the inclusion criteria was anaesthetists using only minimal sedation for the procedure.
Exclusion criteria was severe/profound hearing impairments, patients with intellectual disabilities, patients on psychotropic medications or drugs affecting mood or hemodynamic status, ASA grade 4 and parturients
Exclusion criterion for surgeons included ECCE procedures. Exclusion criteria for anaesthetists was anaesthetists using moderate sedation, or who used non-standard drugs including Droperidol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cataract surgery patients aged 50 years and above, with an acceptable hearing level based on CALFRAST hearing and the ability to wear clip-on on-ear headphones without discomfort. They were required to be mentally and physically capable of informed consent. Patients were also required to be ASA Grade 3 or lower.
- •Surgeons doing phacoemulsification cataract surgeries, and for anaesthetists, the inclusion criteria was anaesthetists using only minimal sedation for the procedure.
排除标准
- •Severe/profound hearing impairments, patients with intellectual disabilities, patients on psychotropic medications or drugs affecting mood or hemodynamic status, ASA grade 4 and parturients
- •Exclusion criterion for surgeons included ECCE procedures. Exclusion criteria for anaesthetists was anaesthetists using moderate sedation, or who used non-standard drugs including Droperidol.
研究组 & 干预措施
Control 1 with no music
This cohort wore non-occlusive earphones but did not listen to music
干预措施: Sennheiser non-occlusive headphones without music (Device)
Experimental Group
The experimental group listened to music and wore Sennheiser non-occlusive headphones
干预措施: Sennheiser non-occlusive headphones (Device)
Control 2 with no music
The control 2 patients did not listen to music nor wore earphones.
干预措施: No Sennheiser non-occlusive headphones (Other)
结局指标
主要结局
Salivary Cortisol
时间窗: 10 minutes post-operatively
10 minutes after the surgery, a saliva sample was collected from the patient in order to test for salivary cortisol as a measure of stress.
次要结局
未报告次要终点
研究者
Anaesthesia
Principal Investigator
National University Hospital, Singapore