Intraoperative anxiety reduction: A comparison of Music and Melatonin interventions.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- To determine the level of patient satisfaction and comfort with the interventions(soothing music and melatonin)by assessing the perioperative anxiety levels with VAS-Anxiety scale and State Trait Anxiety Inventory scale. .
研究概览
简要总结
This study aims to compare the effect of soothing music versus melatonin in management of intraoperative anxiety in patients undergoing surgery under regional anesthesia.
A total sample size of 59 will be employed for recruiting patients in the two groups. After a computer generated randomisation and application of inclusion and exclusion criteria , patients will be allotted to each group. Music group will be made to hear soothing music through headphones intraoperatively, whereas the melatonin group will be given Melatonin orally 2 hours before induction of anaesthesia. Both the groups will be compared on the basis of primary and secondary objectives.
The various time points of the study are 15 minutes before induction of anaesthesia, 30 minutes after induction of anaesthesia, 15 minutes after completion of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients aged 18 to 65 years.
- •Scheduled for elective surgical procedures with time duration of 1 to 3 hours.
- •Undergoing regional anesthesia.
- •Presence of mild to moderate intraoperative anxiety, as assessed through a validated anxiety scale.
- •American Society of Anesthesiologists (ASA) physical status classification I or II.
- •Ability to understand and provide informed consent.
排除标准
- •Age below 18 or above 65 years.
- •Emergency or urgent surgical procedures.
- •Patients undergoing general anesthesia.
- •Severe or uncontrolled anxiety or psychiatric disorders.
- •Patients with a history of allergies or severe adverse reactions to melatonin.
- •Pregnant or breastfeeding women.
- •Participation in another clinical trial concurrently.
结局指标
主要结局
To determine the level of patient satisfaction and comfort with the interventions(soothing music and melatonin)by assessing the perioperative anxiety levels with VAS-Anxiety scale and State Trait Anxiety Inventory scale. .
时间窗: 2 hours before surgery, 15 minutes before induction of anaesthesia, 30 mins after induction of anaesthesia and 15 minutes after completion of surgery.
次要结局
- To assess and compare changes in hemodynamic parameters, including heart rate,respiratory rate, mean arterial pressure, and oxygen saturation(Spo2), between the music group and the melatonin group.(15 minutes before induction of anaesthesia, 30 mins after induction of anaesthesia and 15 minutes after completion of surgery.)
研究者
Abhishek Bharadwaj
Raipur Institute of Medical Sciences