AnxietyNCT05491707

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

A study testing Music in people with Anxiety, run by University of Witwatersrand, South Africa at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 105 years
Conditions the study is for: Anxiety
What is being tested?: Music
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteSouth Africa
Study dates: 4 Jan 2022to 15 Jun 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 105 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Chris Hani Baragwanath Academic hospital
Johannesburg, Gauteng, 1864

Other trials in South Africa

About this study

Read the 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.

Conditions: Anxiety
Being tested: Music
Keywords: Music, Perioperative anxiety, Spinal anaesthesia, Lower limb arthroplasty
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MusicOther
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.

Study groups in NCT05491707
Study group	Role	What they receive
Music	Experimental	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. Receives: Other: Music
Control	No intervention	The control group will not receive music. These patients will receive standard anaesthetic care.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Pre-operative visit (T1)
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.
Measured: 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.
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.
Measured: Pre-operatively and skin incision.
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.
Measured: Pre-operatively, prior to surgery, at skin incision and immediately after surgery.

Secondary outcomes (4)

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.
Measured: 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.
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.
Measured: Pre-operatively, prior to surgery, at skin incision and immediately after surgery.
Describe and compare the total propofol dose between the two groups.
Describe and compare the total propofol dose between the two groups.
Measured: Immediately after surgery
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?
Measured: Immediately after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jan 202215 Jun 2023

First posted8 Aug 2022
Study start4 Jan 2022
Primary completion1 Jul 2022
Study completion15 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnxietyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05491707
Sponsor's protocol ID: M210702
Other IDs: 202106_029
Status last verified: Jun 2023
First submitted: 1 Aug 2022
Last updated: 18 Jun 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in this article, after deidentification will be shared

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Music on Patients' Anxiety During Lower Limb Arthroplasty Procedures Under Spinal Anaesthesia
ClinicalTrials.gov ID: NCT05491707
Acronym / sponsor ID: M210702
Conditions: Anxiety
Keywords: Music, Perioperative anxiety, Spinal anaesthesia, Lower limb arthroplasty
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: University of Witwatersrand, South AfricaUniversity, hospital or other
Study start: 4 Jan 2022 (actual)
Primary completion: 1 Jul 2022 (actual)
Study completion: 15 Jun 2023 (actual)
First posted: 8 Aug 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Music	Experimental	Other: MusicPatients 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.
Control	No intervention	–The control group will not receive music. These patients will receive standard anaesthetic care.

Who may qualify

Ages: 18 to 105 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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),

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MusicPatients 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.	Other	Music

Primary outcome

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 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 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.

4 secondary outcomes

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 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 and compare the total propofol dose between the two groups.
Time frame: Immediately after surgery
Describe patient satisfaction, assessed by a questionnaire, in the intervention group.
Time frame: Immediately after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification will be shared

Related trials for Anxiety

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Samantha A Ballard, MBBCH principal investigator

University of Witwatersrand, South Africa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Music in people with Anxiety, run by University of Witwatersrand, South Africa at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Describe the pre-operative anxiety scores measured by the visual analogue scale for anxiety (time frame: Pre-operative visit (T1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05491707.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.