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

NCT05491707 | Completed

• 2 other identifiers: M210702202106_029
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Music; Perioperative anxiety; Spinal anaesthesia; Lower limb arthroplasty

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Describe the difference in the anxiety scores, on the visual analogue scale for anxiety, between male and female patients.

  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.

  Pre-operatively, prior to surgery, at skin incision and immediately after surgery.

• 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.

  Immediately after surgery

Study Arms (2)

Music

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Music 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.

Music

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead

Study Sites (1)

Chris Hani Baragwanath Academic hospital

Johannesburg, Gauteng, 1864, South Africa

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Samantha A Ballard, MBBCH

  University of Witwatersrand, South Africa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: In this randomised controlled trial, patients will be identified on the arthroplasty lists. Criteria for inclusion will be determined at the pre-operative assessment. After enrolment, participants will be randomised into two groups in a 1:1 ratio, music (intervention group) and no music (control group). Randomisation will be done using a simple randomisation chart.

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 8, 2022
• Study Start: January 4, 2022
• Primary Completion: July 1, 2022
• Study Completion: June 15, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researches who provide a methodologically sound proposal.

Locations

ZA (1)