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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05491707
• Other study ID #: M210702
• Secondary ID: 202106_029
• Status: Completed
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: June 15, 2023

Study information

• Verified date: June 2023
• Source: University of Witwatersrand, South Africa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 15, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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.

Locations

Country	Name	City	State
South Africa	Chris Hani Baragwanath Academic hospital	Johannesburg	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	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