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

University of Witwatersrand

Status: Completed

Conditions: Anxiety

Treatments: Other: Music

Study type: Interventional

Funder types: Other

Identifiers

NCT05491707

202106_029 (Registry Identifier)

M210702

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 105 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Music

Experimental group

Description:

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.

Treatment:

Other: Music

Control

No Intervention group

Description:

The control group will not receive music. These patients will receive standard anaesthetic care.