Comparison of Music and Ambient Noise Cancellation in Patients Undergoing Total Knee Arthroplasty… (NCT06401018) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparison of Music and Ambient Noise Cancellation in Patients Undergoing Total Knee Arthroplasty (TKA)
Turkey (Türkiye)90 participantsStarted 2024-03-15
Plain-language summary
The aim of this clinical trial is to compare the effects of music and ambient noise cancellation during total knee arthroplasty and to analyse the effects on patients. The study will also collect information on patients' functional knee scores and anxiety levels. The main questions to be answered are the following:
Does the blocking of music or ambient noise, which is predicted to reduce anxiety, reduce people's anxiety levels? To what extent are participants affected by ambient noise? Does music or ambient noise blocking lead to an improvement in patients' functional scores?
The researchers will work with 3 groups of patients who will be exposed to ambient noise blocking, music playing and ambient noise during knee replacement surgery.
Participants will do the following:
Be asked questions about anxiety and knee function scores before and after surgery.
Attend clinical examinations at specified times for checks and tests. Outcomes will be assessed and recorded at appropriate times.
Who can participate
Age range
55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients diagnosed with stage 3-4 gonarthrosis
* Patients under spinal anaesthesia
* Patients undergoing unilateral knee replacement
Exclusion Criteria:
* Male patients
* Patients under 55 years of age
* Patients with a history of previous knee joint surgery
* Patients with a known history of rheumatological disease and inflammatory arthropathy
* Patients with dementia
* Patients with psychiatric illness
* Patients taking anxiolytic and antidepressant drugs without any history of psychiatric illness
* Patients with a history of active smoking
* Patients with hearing problems
* Illiterate patients
* Patients under general anaesthesia
* Patients with bilateral prosthesis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Knee Society Score Pre and Post-Operative
Timeframe: Pre-operative, Post-operative 3rd and 6th months