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

NCT ID: NCT05491707

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2023-06-15

Brief Summary

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.

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Music

Intervention Type: OTHER

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Witwatersrand, South Africa

OTHER

Sponsor Role: lead

Responsible Party

Samantha Ballard

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samantha A Ballard, MBBCH

Role: PRINCIPAL_INVESTIGATOR

University of Witwatersrand, South Africa

Locations

Chris Hani Baragwanath Academic hospital

Johannesburg, Gauteng, South Africa

Countries

South Africa

Other Identifiers

202106_029

Identifier Type: REGISTRY

Identifier Source: secondary_id

M210702

Identifier Type: -

Identifier Source: org_study_id