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临床试验/NCT04699084
NCT04699084已完成不适用

The Evaluation of Mozart Music on Pain and Respiratory Rate After Thyroidectomy

Prolepsis Institute for Preventive, Environmental and Occupational Medicine2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Postoperative Pain

研究概览

简要总结

To investigate the effect of Mozart music on postoperative pain and physiological parameters in patients after total thyroidectomy.

详细描述

Postoperative pain is a major concern in postsurgical patients. Meanwhile, there is a general consensus on minimizing the use of analgesic drugs in patients undergoing total thyroidectomy. Therefore, alternative methods need to be investigated in order to reduce postoperative pain. Although the clinical importance of music has been recognised in other pathological situations, further research is needed to investigate the effect of music on postoperative pain.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults scheduled for total thyroidectomy under general anesthesia

排除标准

  • Visual impairments
  • Hearing impairments
  • Severe anxiety or other psychiatric disorders
  • History of chronic pain
  • Past complications during anesthesia or surgery
  • American Society of Anesthesiologists (ASA) physical status beyond II

结局指标

主要结局

Postoperative Pain

时间窗: Change of VAS was evaluated; from the beginning (time of arrival at the PACU, baseline), to the middle (10 minutes after surgery), to the end of the music intervention (20 minutes after surgery) at the PACU and to 2 hours after surgery in the ward.

Postoperative Pain was measured with the Visual Analogue Scale (VAS). This is a straight horizontal line of fixed length, usually 100 mm. The ends of the line are defined as the extreme limits of the measured parameter (pain). Specifically, the left end signifies the complete absence of pain and the right end represents the worst possible pain. Patients were asked to rate their pain by indicating a point on the straight line. Higher VAS scores mean more pain intensity. The more is the reduction of VAS score from the baseline measurement, the better is the outcome.

次要结局

  • Heart rate(Change of heart rate was evaluated during the first postoperative day.)
  • Respiratory rate(Change of respiratory rate was evaluated during the first postoperative day.)
  • Systolic and diastolic blood pressure(Change of blood pressure was evaluated during the first postoperative day.)
  • Oxygen saturation(Change of oxygen saturation was evaluated during the first postoperative day.)

研究者

发起方
Prolepsis Institute for Preventive, Environmental and Occupational Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dimitrios Linos

Principal Investigator

Prolepsis Institute for Preventive, Environmental and Occupational Medicine

研究点 (2)

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