Skip to main content
OpenTrials
Completed

NCT Number: NCT05491707

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chris Hani Baragwanath Academic hospital

Johannesburg, Gauteng, 1864, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Describe the pre-operative anxiety scores measured by the visual analogue scale for anxiety

    Time frame: Pre-operative visit (T1)

    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.

  2. 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.

    Time frame: Pre-operatively and skin incision

    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.

  3. 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.

    Time frame: 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. 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.

  4. 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.

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

    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.

Secondary outcomes

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

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

    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.

  2. Describe the difference in anxiety scores, on the visual analogue scale for anxiety, between knee and hip arthroplasty.

    Time frame: 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. 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.

  3. Describe and compare the total propofol dose between the two groups.

    Time frame: Immediately after surgery

    Describe and compare the total propofol dose between the two groups.

  4. Describe patient satisfaction, assessed by a questionnaire, in the intervention group.

    Time frame: Immediately after surgery

    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?

Sponsors and collaborators

Lead sponsor

University of Witwatersrand, South Africa

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 8, 2022
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.