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临床试验/CTRI/2025/09/095334
CTRI/2025/09/095334尚未招募不适用

A prospective comparative study of the effect of binaural music versus midazolam on intraoperative anxiety in patients undergoing lower limb orthopedic surgery under spinal anaesthesia

LAXMI P MATHAPATI1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2025年10月4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
162
试验地点
1
主要终点
To know the difference of the effect of binaural music and midazolam on patients anxiety intraoperatively

研究概览

简要总结

Pre-Anaesthetic Evaluation:

History: Information regarding any pre-existing medical conditions, prior surgical experiences, exposure to anaesthesia, and past hospitalizations will be gathered.

Clinical Assessment: Evaluation of the patient’s overall health. Baseline vital signs, including heart rate, systolic and diastolic blood pressure, respiratory rate, and mean arterial blood pressure, will be documented.

Pre-operatively:

Preoperative STAI-6 scores will be taken to know the anxiety of patient.

Intra-operatively:

Patients were given spinal block by using 0.5% hyperbaric bupivacaine.

After patients were put on noise cancelling head phones and binaural music was played in group I, in group II intravenous midazolam 0.02mg/kg will be given group III is taken as control group without any music or midazolam.

The hemodynamic parameters were noted at 5, 10 ,20, 40 ,60 and every 20mins till surgery gets over.

Ramsay sedation score were noted every half an hour of surgery.

The noted parameters are SBP, DBP, MBP, HR.

Post-operatively:

Post operative STAI-6 scores will be taken to know the anxiety and VAS-S will be taken to know satisfaction of patient.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • Adults of either sex age between 18 to 60 years ASA grade I and II Patients undergoing lowerlimb orthopedic surgeries under spinal anaesthesia.

排除标准

  • Patients with hearing impairment patients with spinal deformity and mental illness pregnant women and lactating mothers.

结局指标

主要结局

To know the difference of the effect of binaural music and midazolam on patients anxiety intraoperatively

时间窗: Baseline, | 5mins, 10mins, 30mins, | 1hr and immediate post operative

次要结局

未报告次要终点

研究者

发起方
LAXMI P MATHAPATI
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Laxmi mathapati

BLDEA(deemed to be university)

研究点 (1)

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