CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 85 enrolled
Drug / intervention
Sedation with midazolam +1 moredrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03882541
NCT03882541N/ACompleted

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

Consorci Sanitari de l'Anoia·interventional·Posted Mar 20, 2019·Updated Mar 20, 2019

In Brief

A clinical study evaluating Music therapy and Sedation with midazolam for Anxiety and 4 related conditions. Completed, enrolled 85 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
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Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 20, 2019
Enrollment StartJan 8, 2017
Primary CompletionJan 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7.3 years ago

Interventions

Music therapyother

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

Sedation with midazolamdrug

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