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

NCT03882541 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2019-03-20

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Music therapy

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

DRUG

Sedation with midazolam

To evaluate the effect of sedation (in comparation with music group) in patients anxiety and pain durin perioperative process in surgical intervention with regional anesthesia without music

Sponsors & Collaborators

  • Consorci Sanitari de l'Anoia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-08
Primary Completion
2018-01-30
Completion
2018-01-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03882541 on ClinicalTrials.gov