Could Music be an Alternative to Sedation in Patients Treated Total Knee Arthroplasty With Regional Anesthesia?

• Status: Completed
• Trial end date: 2018-01-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Consorci Sanitari de l'Anoia
• Treatments: Anesthetics; Midazolam

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.