Effect of Music on Patients' Anxiety During Lower Limb Arthroplasty Procedures Under Spinal Anaesthesia

The aim of this study is to compare the effect of listening to music, to a control group (no music), on peri-operative anxiety using the validated VAS-A, in patients undergoing lower limb arthroplasty procedures under spinal anaesthesia.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Other: Music

Detailed Description

Music is becoming an increasingly popular adjunct to traditional medical therapies. International studies have shown the numerous benefits of music in a medical setting. Music has been used effectively to decrease patients' anxiety under neuraxial anaesthesia for caesarean section. There is currently a lack of evidence supporting the use of music to reduce patients' anxiety under neuraxial anaesthesia for lower limb arthroplasty procedures. The worldwide growth of the ageing population has led to an increased demand for arthroplasty. It is imperative that the anaesthetic technique used for this procedure is both safe and is associated with high levels of patient satisfaction. The purpose of this study is to compare the effect of music, to a control, on peri-operative anxiety in patients undergoing lower limb arthroplasty procedures under spinal anaesthesia.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 1864
      • Chris Hani Baragwanath Academic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• all patients, aged 18 years and older,
• American Society of Anaesthesiologists (ASA) class I, II or III,
• patients undergoing primary hip or knee arthroplasty surgery under spinal anaesthesia,
• patients with the mental capacity to consent to the study.

Exclusion Criteria:

• patients with significant visual or hearing loss,
• patients with any contra-indications to spinal anaesthesia,
• patients with any contra-indications to moderate sedation including moderate to severe obstructive sleep apnoea (indicated by a "STOPBANG" score of 5-8) (46),
• patients with pre-existing diagnosed anxiety disorders or other serious mental disturbances,
• revision arthroplasty (this may require deviation from the standardised anaesthetic technique used for this trial),
• anxious patients who cannot be reassured and require additional anxiolytic agents.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music; Patients in the intervention group will receive music after the ASA monitors are applied. The music will be played at a self-selected volume, on Pro Bass Swagger Series Aux disposable earphones and will be played for the duration of the surgical procedure. The music will be played from an iPhone which will be placed in a plastic bag for infection control purposes. These patients will receive standard anaesthetic care.	Other: Music; Patients will choose a genre of music from the following list; pop, gospel, classical, jazz, and soul, at the preoperative visit. This will be played on disposable ear phones at a self-selected volume for the duration of the surgical procedure.
No Intervention: Control; The control group will not receive music. These patients will receive standard anaesthetic care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the pre-operative anxiety scores measured by the visual analogue scale for anxiety	Describe the pre-operative anxiety scores measured by the visual analogue scale for anxiety in both the intervention and the control group. The minimum score on this scale is zero and the maximum score is ten. Zero indicates that the patients have no anxiety and ten indicates that the patient is extremely anxious.	Pre-operative visit (T1)
Describe and compare the change in anxiety scores, on the visual analogue scale for anxiety, at the pre-operative visit (T1) and at skin incision (T3) in the control group.	Describe and compare the change anxiety scores, visual analogue scale for anxiety, at the pre-operative visit (T1) and at skin incision (T3) in the control group. The minimum score on this scale is zero and the maximum score is ten. Zero indicates that the patients have no anxiety and ten indicates that the patient is extremely anxious.	Pre-operatively and skin incision
Describe and compare the change in anxiety scores, on the visual analogue scale for anxiety, at the pre-operative visit (T1) and at skin incision (T3) in the music group.	Describe and compare the change in anxiety scores, on the visual analogue scale for anxiety, at the pre-operative visit (T1) and at skin incision (T3) in the music group. The minimum score on this scale is zero and the maximum score is ten. Zero indicates that the patients have no anxiety and ten indicates that the patient is extremely anxious.	Pre-operatively and skin incision.
Describe and compare the change in anxiety scores, on the visual analogue scale for anxiety, at each time point (T1-T4) between the control group and the music group.	Describe and compare the change in anxiety scores, on the visual analogue scale for anxiety, at each time point (T1-T4) between the control group and the music group. The minimum score on this scale is zero and the maximum score is ten. Zero indicates that the patients have no anxiety and ten indicates that the patient is extremely anxious.	Pre-operatively, prior to surgery, at skin incision and immediately after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the difference in the anxiety scores, on the visual analogue scale for anxiety, between male and female patients.	Describe the difference in the anxiety scores, on the visual analogue scale for anxiety, between male and female patients. The minimum score on this scale is zero and the maximum score is ten. Zero indicates that the patients have no anxiety and ten indicates that the patient is extremely anxious.	Pre-operatively, prior to surgery, at skin incision and immediately after surgery.
Describe the difference in anxiety scores, on the visual analogue scale for anxiety, between knee and hip arthroplasty.	Describe the difference in anxiety scores, on the visual analogue scale for anxiety, between knee and hip arthroplasty. The minimum score on this scale is zero and the maximum score is ten. Zero indicates that the patients have no anxiety and ten indicates that the patient is extremely anxious.	Pre-operatively, prior to surgery, at skin incision and immediately after surgery.
Describe and compare the total propofol dose between the two groups.	Describe and compare the total propofol dose between the two groups.	Immediately after surgery
Describe patient satisfaction, assessed by a questionnaire, in the intervention group.	Describe patient satisfaction, assessed by a questionnaire, in the intervention group. The questionnaire consists of five questions which patients will answer as either not at all, maybe, completely. The questions are: 1) Did the patient feel that the music decreased their anxiety? 2) Did the patient feel that the music provided calmness? 3) 3) Did the patient feel that they experienced less pain? 4) Would they request music again if coming for a similar procedure? 5) Would they recommend music to friends and family?	Immediately after surgery

Collaborators and Investigators

• Sponsor: University of Witwatersrand, South Africa
• Investigators: Principal Investigator: Samantha A Ballard, MBBCH, University of Witwatersrand, South Africa

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Music; Spinal anaesthesia; Perioperative anxiety; Lower limb arthroplasty
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: M210702; 202106_029 (Registry Identifier: The National Health Research Database)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification will be shared
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Researches who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No