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临床试验/CTRI/2025/07/091903
CTRI/2025/07/091903尚未招募4 期

To assess the effects of binaural beat music and active noise cancellation on anxiety and intraoperative anaesthetic requirements in patients undergoing laproscopic cholecystectomy under general anaesthesia.

Swami Rama Himalayan University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年8月11日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
90
试验地点
1
主要终点
To study and compare effects of music and noise cancellation on intra operative anaesthetic drug requirements and post operative analgesic needs.

研究概览

简要总结

Preoperative anxiety is a common concern among surgical patients and can lead to increase anaesthetic requirements, delayed recovery and heightened peri operative complications. The topic investigates the effect of binaural beat music and active noise cancellation on anxiety levels and anaesthetic requirements in patients undergoing laproscopic cholecystectomy under general anaesthesia. The aim is to determine whether these non pharmacological interventions can reduce postoperative anxiety and lower  intraoperative anaesthetic consumption, potentially improving patient outcomes and enhancing perioperative care.

Aim and objective-

1- to compare the effects of music with noise cancellation v/s active noise cancellation on intra operative anaesthetic drug requirements as well as post operative analgesic requirements on patients undergoing laproscopic cholecystectomy under general anaesthesia.

2-  to assess the effects of music with noise cancellation and active noise cancellation on the anxiety relief in each group of patients undergoing laparoscopic cholecystectomy under general anesthesia.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Either sex, patients in age group of 18 to 60 years, ASA grade 1 or 2, undergoing elective laproscopic cholecystectomy requiring general anaesthesia with LMA insertion, duration of surgery to be less than 120 minutes.

排除标准

  • ASA grade 3 or 4, patients less than 18 and more than 60 years, history of any psychiatric illness, patients with active URTI, MPG grade 3 or 4, anticipated difficult airway, obesity with BMI more than 30, patients with any ear deformity, infection, vertigo, tinnitus, hearing loss, Patients with significant cardiovascular and respiratory diseases and renal diseases Patients with GERD, pregnancy , cervical spine pathology Patient giving negative consent for research.

结局指标

主要结局

To study and compare effects of music and noise cancellation on intra operative anaesthetic drug requirements and post operative analgesic needs.

时间窗: 1- immediately after attachment of headphones after induction. | 2-immediately before creation of pneumoperitoneum | 3- throughout pneumoperitoneum | 4-immediately before extubation | 5- after extubation. | 6- first call for need of analgesics

次要结局

  • To assess the effects of music on anxiety relief(State trait anxiety inventory-6 score calculation both preoperatively and post operatively)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Nipunika Agrawal

Himalayan Institute Of Medical Sciences

研究点 (1)

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