Effect of Music on Patients' Anxiety During Lower Limb Arthroplasty Procedures Under Spinal Anaesthesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 105 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
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.
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.
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
- 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 patient satisfaction, assessed by a questionnaire, in the intervention group.(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)
Investigators
Samantha Ballard
Principal investigator
University of Witwatersrand, South Africa