跳至主要内容
临床试验/CTRI/2024/07/071113
CTRI/2024/07/071113尚未招募2/3 期

The impact of Binaural beat music and noise cancelling headphones on intraoperative anxiety and pain Catastrophizing in patients undergoing lower limb surgeries under spinal Anaesthesia - A Randomised Controlled study

Dr S Preethi1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年8月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To determine the effect of binaural beat music and active noise cancellation on intraoperative anxiety using State-Trait Anxiety Inventory -6(STAI-6) Score in patients pre and post surgery.

研究概览

简要总结

Intraoperative anxiety is a challenge in patients undergoing lower limb surgery. An ideal intraoperative anxiety management technique must be effective in repressing the pain catastrophized as well as the chronic pain while having no side effects on the patient.

Such a effect can be brought up with the usage of binaural beat music and noise cancelling headphones. So  the study aims to compare the effect on intraoperative anxiety and pain catastrophizing with the use of binaural beat music , Noise cancelling headphones separately with a control group using none of the above mentioned.

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 75.00 Year(s)(—)
性别
All

入选标准

  • American Society Of Anaesthesiology Class I / II Patients planned for elective lower limb surgeries.

排除标准

  • Patient refusal Hearing impairment Patients having psychiatric disorders and those who are having difficulty in comprehension Contraindications to spinal anaesthesia Pregnant and Lactating mothers.

结局指标

主要结局

To determine the effect of binaural beat music and active noise cancellation on intraoperative anxiety using State-Trait Anxiety Inventory -6(STAI-6) Score in patients pre and post surgery.

时间窗: The STAI-6 score will be assessed preoperatively 30 minutes before shifting the patient to OT and postoperatively 2 hours after the surgery.

次要结局

  • To evaluate the effect of music/noise cancellation on patient satisfaction,(sedation,)

研究者

发起方
Dr S Preethi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Preethi S

Sri Venkateshwaraa Medical College Hospital and Research Centre

研究点 (1)

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