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临床试验/NCT03882541
NCT03882541已完成不适用

Could Music be an Alternative to Sedation in Patients Treated Total Knee Arthroplasty With Regional Anesthesia?: A Randomized Clinical Trial

Consorci Sanitari de l'Anoia0 个研究点目标入组 85 人开始时间: 2017年1月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
85
主要终点
Anxiety State-Trait Anxiety Inventory (STAI)

研究概览

简要总结

Background: Anxiety is a common phenomenon in hospitalized patients. In order to reduce it during the surgical procedure, sedatives and anxiolytics are used, which can cause undesirable side effects for patients. Music is described as an effective tool to reduce this anxiety suffered by the patient in the perioperative process.

Objectives: To evaluate the effect of music in patients anxiety and pain during perioperative process in surgical intervention with regional anaesthesia without sedatives or anxiolytics.

Design: A randomized parallel clinical trial study with single-blinded and three harms.

Setting: Operating theater of a public district hospital (serving around 111.000 people) Participants: All patients operated of Total Knee Arthroplasty (TKA) with regional anaesthesia with age between 50 and 85 years old within level I or II of the classification of the American Society of Anaesthesiologists (ASA).

Methods: A total of 81 patients for TKA were randomly assigned to: a control group (headphones without music, without sedation), a sedative group (headphones without music, with sedation) and a experimental group (headphones with music, without sedation). 27 participants for each group. All the participants were using headphones so that it was a single-blinded study. The experimental group were provided with the same music, Piano Guys group. The variables of study were: the pain was measured by vale numerical scale (VNS), the anxiety was measured by the use of State-Trait Anxiety Inventory (STAI), heart rate (HR) variability, blood pressure (BP) variability, saturation of oxygen (Sat02).

Relevance to Clinical Practice: sedation that can causes unwanted side effects by surgical patients can be replaced by music. The music decrease anxiety and pain values in orthopaedic surgery patients.

Keywords: Anxiety, Drugs, Music therapy, Pain, Perioperative, Surgery.

详细描述

  1. Introduction Patients generally experience high levels of anxiety when are hospitalized to undergo surgery and other invasive procedures. Anxiety is an emotional state or condition characterized by stress and unpleasant feelings. Awake patients in the operating theatre are afraid of they will feel pain during the surgical and/or regional anaesthetic procedures, which contributes to increased anxiety. Patients operated under regional anaesthesia are in particular need of sedation during the perioperative period. The purpose of the sedation is to ensure comfort, full cooperation and cardiovascular stability of patients who can maintain a patent airway. However, because of the adverse effects (respiratory depression, nausea, vomiting), optimal patient satisfaction is hard to achieve. Additionally, intraoperative anxiety is often associated with a greater incidence of pain after surgery.

On the other hand, toxicity of general anaesthetics has been recently studied from its neurotoxic effect to neuroapoptosis. In some cases, they may cause postoperative cognitive dysfunction, and other side effects known as hypoxemia, respiratory depression and increased morbidity and mortality.

Music has been suggested as a potential intervention to reduce anxiety and pain in the operating room environment. Systematic meta-analysis conducted by Nilsson revealed that 50% of studies (12 of 24) published between January 1995-January 2007 found significant reductions in anxiety scores as measured by STAI. and then more studies have been carried out on the benefits of music, which have continued to show that music reduces preoperative and postoperative anxiety and also reduces postoperative pain.

There are also studies that conclude that patients to listening music require less midazolam to achieve a similar degree of relaxation as controls in ambulatory surgery patients and that the relaxing music a useful alternative to midazolam for pre-medication before surgery.

Music holds considerable promise as an adjuvant pain management therapy and in mild cases may be used to supplement, perhaps even replace, pharmaceutical interventions before, during, and after painful procedures. The maximal reduction in pain intensity levels is 0.9 units on a zero to ten scale; although this difference reaches statistical significance, its clinical importance is unclear.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age with range from 50-85 years old
  • Had regional anaesthesia
  • Duration of surgery not exceeding two hours
  • Was willing to participate in the study and signed an informed consent form

排除标准

  • Those patients with classification system of American Society of Anaesthesiologist (ASA) 3 or 4
  • Allergic drugs used
  • Psychiatric patients or cognitive issues
  • Patients with whom we have communication problems
  • Patients who for any reason need another type of anaesthesia.

研究组 & 干预措施

sedative group

Active Comparator

headphones without music, with sedation

干预措施: Sedation with midazolam (Drug)

experimental group

Experimental

headphones with music, without sedation

干预措施: Music therapy (Other)

结局指标

主要结局

Anxiety State-Trait Anxiety Inventory (STAI)

时间窗: 10 minutes

The State-Trait Anxiety Inventory (STAI) consists of two different parts, termed STAI-Trait Anxiety Inventory (STAI-TA) and STAI-State Anxiety Inventory (STAI-SA). This test requires patients to complete a 40-item, 20 items measuring state anxiety and 20 items measuring trait anxiety (Spielberger et al.,1970) adding each one of the items of each subscale. The score can range between 0 and 60, representing the highest and lowest levels of anxiety, respectively. In our study, STAI-TA test results were evaluated preoperatively. The STAI-SA was performed during the waiting room (Orthopaedic unit, 30 minutes before surgery) and postoperative period in Post anaesthesia care unit (PACU) (recovery period, 30 minutes after surgery). There are no cut points, but direct scores are transformed into centiles based on sex and age.

次要结局

  • Pain Vale Numerical Scale (VNS)(3 minutes)

研究者

发起方
Consorci Sanitari de l'Anoia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sílvia Roca

Nurse

Consorci Sanitari de l'Anoia

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