The Effect of Music Versus Midazolam on Perioperative Anxiety of Obese Patients Under Spinal Anesthesia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety immediately after spinal anesthesia.
研究概览
简要总结
The goal of this clinical trial is to learn whether music or midazolam has a greater anxiolytic effect on obese patients undergoing spinal anesthesia. It will also determine the safety of music compared to midazolam in this population (differences in blood pressure, heart rate, oxygen saturation). The main question to answer: Music or midazolam is more effective in reducing anxiety in obese patients under spinal anesthesia?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who are > 18 years old
- •patients with Body Mass Index -ΒΜΙ>30 kg/m2
- •patients who will give informed consent in receiving spinal anaesthesia
- •patients who will give informed consent in participating in the study
排除标准
- •absolute contraindications of spinal anaesthesia,
- •severe psychiatric, cognitive or sensory impairment
- •mother language other than greek,
- •known hypersensitivity to midazolam,
- •renal impairment
研究组 & 干预措施
Music group
The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery.
干预措施: Music intervention (Other)
Midazolam group
The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia.
干预措施: Midazolam (sedative) (Drug)
结局指标
主要结局
Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety immediately after spinal anesthesia.
时间窗: State -anxiety is measured immediately after spinal anesthesia.
State -anxiety, how the person feels at the moment, is measured by means of Spielberger State-Trait Anxiety Inventory (STAI). STAI tool scores range from 20 to 80, with higher scores indicating higher anxiety. Although it is difficult to represent severity of anxiety with a numerical cut-off, a score of 50 or higher has been shown to be associated with a higher level of anxiety.
次要结局
- Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety immediately after surgery(Immediately after surgery)
- Time performing spinal anesthesia(From the start of positioning maneuvers for spinal anesthesia to the spinal needle removal)
- Patient satisfaction 24 hours after surgery(24 hours after surgery)
- Communication difficulties between the patient and the anesthesiologist.(Immediately after surgery)
- Communication difficulties between the anesthesiologist and the patient.(Immediately after surgery)
- Adverse outcomes(During the operation)
研究者
Maria Diakomi
Consultant Anaesthesiologist
General Hospital of Kavala