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临床试验/CTRI/2025/07/090982
CTRI/2025/07/090982尚未招募不适用

Comparing Binaural Beat Music and Noise Cancelling Headphones for reducing intraoperative anxiety in patients undergoing surgery under spinal anaesthesia - A Randomized Controlled Study

Ballari Medical College and research centre Ballari1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年8月1日最近更新:

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

发起方
Ballari Medical College and research centre Ballari
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Navya G

Ballari medical College and research centre Ballari

研究点 (1)

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