Clinical trial NCT05491707: Effect of Music on Patients' Anxiety During Lower Limb Arthroplasty Procedures Under Spinal Anaesthesia
Official title: Effect of Music on Patients' Anxiety During Lower Limb Arthroplasty Procedures Under Spinal Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Music
Perioperative anxiety
Spinal anaesthesia
Lower limb arthroplasty
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Describe the pre-operative anxiety scores measured by the visual analogue scale for anxiety
timeFrame: Pre-operative visit (T1)
measure: 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.
timeFrame: Pre-operatively and skin incision
measure: 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.
timeFrame: Pre-operatively and skin incision.
measure: 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.
timeFrame: Pre-operatively, prior to surgery, at skin incision and immediately after surgery.
Secondary outcomes:
measure: Describe the difference in the anxiety scores, on the visual analogue scale for anxiety, between male and female patients.
timeFrame: Pre-operatively, prior to surgery, at skin incision and immediately after surgery.
measure: Describe the difference in anxiety scores, on the visual analogue scale for anxiety, between knee and hip arthroplasty.
timeFrame: Pre-operatively, prior to surgery, at skin incision and immediately after surgery.
measure: Describe and compare the total propofol dose between the two groups.
timeFrame: Immediately after surgery
measure: Describe patient satisfaction, assessed by a questionnaire, in the intervention group.
timeFrame: Immediately after surgery
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Academic hospital
state: Gauteng
Study officials:
affiliation: University of Witwatersrand, South Africa
name: Samantha A Ballard, MBBCH
role: PRINCIPAL_INVESTIGATOR
References: