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

NCT03882541 | Completed DMC

• 1 other identifier: PRCSA0077
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief 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

Anxiety; Surgery; Drug Toxicity; Anesthesia; Pain

Keywords

Anxiety; Pain; perioperative; Surgery; Music Therapy; Drugs

Outcome Measures

Primary Outcomes (1)

• Anxiety State-Trait Anxiety Inventory (STAI)

  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.

  10 minutes

Secondary Outcomes (1)

• Pain Vale Numerical Scale (VNS)

  3 minutes

Other Outcomes (6)

• Heart Rate (pulsation for minute)

  15 minutes for 1 hour

• Blood Preasure (mmHg)

  15 minutes for 1 hour

• Oxygen Saturation (%)

  15 minutes for 1 hour

Study Arms (3)

Control group

NO INTERVENTION

headphones without music, without sedation

sedative group

ACTIVE COMPARATOR

headphones without music, with sedation

Drug: Sedation with midazolam

experimental group

EXPERIMENTAL

headphones with music, without sedation

Other: Music therapy

Interventions

Music therapy OTHER

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

experimental group

Sedation with midazolam DRUG

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

sedative group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari de l'Anoia: lead

Related Publications (17)

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MeSH Terms

Conditions

Anxiety Disorders; Drug-Related Side Effects and Adverse Reactions; Pain

Interventions

Music Therapy; Midazolam

Condition Hierarchy (Ancestors)

Mental Disorders; Chemically-Induced Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: March 20, 2019
• Study Start: January 8, 2017
• Primary Completion: January 30, 2018
• Study Completion: January 30, 2018
• Last Updated: March 20, 2019

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share