Effect of music therapy on anxiety, stress and sedative requirements in patients undergoing lower limb orthopedic surgery under spinal anaesthesia: A randomized controlled study.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- To compare the effect of music therapy on anxiety, stress, and sedative requirements in patients undergoing lower limb orthopedic surgery under spinal anaesthesia.
研究概览
简要总结
INTRODUCTION:Music is capable of evoking strong positive emotions, and elevating the mood of individual . These effects can potentially be used in clinical settings, where negative emotions such as pain often reduce an individual’s subjective well-being. Music has been reported to reduce stress before,during, and after medical procedures including surgery, angiography, and colonoscopy . Correspondingly, some studies suggest that listening to music reduces cortisol levels before, during and after such procedures. In relation to the lower stress levels of patients listening to music, many studies reported that sedative requirements are also reduced in patients undergoing surgery under regional anesthesia combined with sedation . Similar effects have been reported for sedated patients treated in intensive care units. The stress- and pain-reducing effects of music are presumably due to its capability to engage perceptual, emotional, and cognitive processes that (a) interfere with the perception of the noise of the operating theater, (b) consume attentional resources, and (c) evoke feelings of pleasure which interact with pain and unpleasant affects related to the surgical procedure. Cortisol (a corticosteroid hormone that is crucial for glucose metabolism, inflammation suppression, and stress adaptation) is the biochemical that has been investigated most frequently with regard to music.
In addition to such hormonal effects, stress levels also affect immune system activity; one of these effects is a transient increase of immunoglobulin A (IgA) in response to an increase in HPA axis activity . Effects of music on serum IgA concentrations were only investigated under general anesthesia, and statistically not significant. Nevertheless, some non-clinical studies suggest effects of music listening on salivary IgA concentrations in awake, healthy individuals . In the present aim of study is to compare the effect of music therapy on anxiety, stress, and sedative requirements in patients undergoing lower limb orthopedics surgery under spinal anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •ASA Physical status classification I and II
- •Patients aged between 18-65years.
- •Patients body mass index between 18-25 kg/m
- •Patients posted for lower limb orthopedic surgeries under spinal anaesthesia.
排除标准
- •Patients who refused to listen music.
- •Having hearing abnormality.
- •History of head and neck surgery
- •Having mental or psychiatric disorders.
结局指标
主要结局
To compare the effect of music therapy on anxiety, stress, and sedative requirements in patients undergoing lower limb orthopedic surgery under spinal anaesthesia.
时间窗: 10 mints before surgery to 12 hours after surgery
次要结局
- 1.To evaluate total sedative requirements Bispectral index(BIS) as end point inpatients between two groups.(2.To compare the anxiety levels by using the state-trait anxiety inventory and changes in the hemodynamics parameters in patients between two groups.)
研究者
Dr Thamaraikkannan
Uttar Pradesh University of Medical Sciences, Saifai
