Back to resultsEffect of Music on Patients' Anxiety During Lower Limb Arthroplasty Procedures Under Spinal Anaesthesia
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Music
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Music, Perioperative anxiety, Spinal anaesthesia, Lower limb arthroplasty
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.
Sites / Locations
- Chris Hani Baragwanath Academic hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Music
Control
Arm Description
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.
The control group will not receive music. These patients will receive standard anaesthetic care.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Describe and compare the total propofol dose between the two groups.
Describe and compare the total propofol dose between the two groups.
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?
Full Information
NCT ID
NCT05491707
First Posted
August 1, 2022
Last Updated
June 15, 2023
Sponsor
University of Witwatersrand, South Africa
1. Study Identification
Unique Protocol Identification Number
NCT05491707
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
June 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Witwatersrand, South Africa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Music, Perioperative anxiety, Spinal anaesthesia, Lower limb arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will not receive music. These patients will receive standard anaesthetic care.
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
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 Outcome Measure Information:
Title
Describe the pre-operative anxiety scores measured by the visual analogue scale for anxiety
Description
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.
Time Frame
Pre-operative visit (T1)
Title
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.
Description
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.
Time Frame
Pre-operatively and skin incision
Title
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.
Description
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.
Time Frame
Pre-operatively and skin incision.
Title
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.
Description
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.
Time Frame
Pre-operatively, prior to surgery, at skin incision and immediately after surgery.
Secondary Outcome Measure Information:
Title
Describe the difference in the anxiety scores, on the visual analogue scale for anxiety, between male and female patients.
Description
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.
Time Frame
Pre-operatively, prior to surgery, at skin incision and immediately after surgery.
Title
Describe the difference in anxiety scores, on the visual analogue scale for anxiety, between knee and hip arthroplasty.
Description
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.
Time Frame
Pre-operatively, prior to surgery, at skin incision and immediately after surgery.
Title
Describe and compare the total propofol dose between the two groups.
Description
Describe and compare the total propofol dose between the two groups.
Time Frame
Immediately after surgery
Title
Describe patient satisfaction, assessed by a questionnaire, in the intervention group.
Description
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?
Time Frame
Immediately after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samantha A Ballard, MBBCH
Organizational Affiliation
University of Witwatersrand, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chris Hani Baragwanath Academic hospital
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1864
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification will be shared
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Researches who provide a methodologically sound proposal.
Learn more about this trial
Effect of Music on Patients' Anxiety During Lower Limb Arthroplasty Procedures Under Spinal Anaesthesia
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