Comparing Binaural Beat Music and Noise Cancelling Headphones for reducing intraoperative anxiety in patients undergoing surgery under spinal anaesthesia - A 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
- 140
- 试验地点
- 1
- 主要终点
- Comparison of change in intraoperative anxiety levels
研究概览
简要总结
The study will include adult patients of either gender, aged 18 to 60 years, with ASA physical status I or II, scheduled for lower abdominal surgeries under spinal anaesthesia. Patients with hearing impairment, psychiatric or neurological disorders, contraindications to spinal anaesthesia, and pregnant or lactating women will be excluded.
Participants will be randomly assigned to one of two groups: Group N (noise-cancelling headphones without music) or Group B (binaural beat music through headphones). Randomisation will be done using computer-generated numbers and allocation will follow the sequentially numbered opaque sealed envelope technique. Patients will be blinded to the intervention.
During preanaesthetic evaluation, patients will be briefed about the interventions, and baseline vitals along with STAI-6 anxiety scores will be recorded. Spinal anaesthesia will be administered, and once a sensory level of T8 is confirmed, the assigned intervention will commence. Intraoperative monitoring will include heart rate, blood pressure, Ramsay Sedation Scale, and communication difficulty using a Likert scale. These will be recorded at specified intervals. At the end of surgery, STAI-6 and VAS-S (Visual Analogue Scale for Satisfaction) will be documented. Headphones will be sanitized after each use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients undergoing lower abdominal surgery under spinal anaesthesia ASA 1 and 2 Age 18-60 yrs Male and Female gender Patients able to provide written and informed consent.
排除标准
- •Patients with hearing impairment Pre-existing psychiatric or neurological disorders.
- •Contraindications to spinal anaesthesia Pregnant and lactating mother Patients with chronic use of anxiolytics and sedatives.
结局指标
主要结局
Comparison of change in intraoperative anxiety levels
时间窗: 30min after spinal anaesthesia
次要结局
- Intraoperatively(Sedation)
研究者
Navya G
Ballari medical College and research centre Ballari
