Evaluating music therapy as a perioperative anxiolytic in patients undergoing spinal anaesthesia for Orthopaedic Lower Limb Surgeries -A prospective randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate music therapy as a perioperative anxiolytic in patients undergoing orthopaedic lower limb surgeries under spinal anaesthesia
研究概览
简要总结
Need for Study
Anxiety is a pervasive concern for patients undergoing orthopedic lower limb surgeries, potentially leading to increased stress, discomfort, and analgesic requirements. Spinal anesthesia, although effective, can provoke anxiety due to the unfamiliar environment, needle insertion, and temporary loss of motor control. Current anxiolytic regimens often rely on pharmacological interventions, which may have undesirable side effects.
Music therapy has emerged as a promising adjuvant anxiolytic strategy, leveraging the calming effects of music to mitigate anxiety. However, its efficacy in the context of spinal anesthesia for orthopedic lower limb surgeries remains understudied.
This randomized controlled study aims to investigate the anxiolytic effects of music therapy as an adjunct to standard care in patients undergoing spinal anesthesia for orthopedic lower limb surgeries, providing valuable insights into the potential benefits of this non pharmacological intervention.
**Objectives of Study:**To evaluate music therapy as a perioperative anxiolytic in patients undergoing orthopaedic lower limb surgeries under spinal anaesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •1.American Society of Anaesthesiologists Classification: Patients classified as ASA Grade I or II.
- •2.Age: Patients under 18-59 years old.
- •3.Lower limb Orthopaedic surgical procedures performed in Supine position lasting for 3 hours or less.
排除标准
- •1.Patient refusal 2.Any Psychiatric illness or memory impairment.
- •3.Pregnancy 4.Hearing disability.
结局指标
主要结局
To evaluate music therapy as a perioperative anxiolytic in patients undergoing orthopaedic lower limb surgeries under spinal anaesthesia
时间窗: Patients anxiety levels will be assessed based on the Visual Analog Scale for Anxiety (VASA) score preoperatively 15 minutes before anesthesia, 30 min after spinal anesthesia and postoperatively 60 | minutes after the surgical procedure
次要结局
- To evaluate the impact of music therapy on:(1.Hemodynamic parameters)
研究者
ALBIN KURIAKOSE
St. Johns Medical College and Hospital, Bangalore