Comparison of Music and Ambient Noise Cancellation in Patients Undergoing Total Knee Arthroplasty (TKA)

Not Applicable

Recruiting

• Conditions: Anxiety; Knee Osteoarthritis; Post Operative Pain; Noise Exposure
• Interventions: Procedure: Music is played but noise is not cancelled; Procedure: No noise cancellation and no music playing; Procedure: Noise cancelled but not allowed to listen to music

• Registration Number: NCT06401018
• Lead Sponsor: Ankara City Hospital Bilkent

Brief 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.

Detailed Description

Osteoarthritis is a degenerative and progressive knee disease that causes progressive loss of articular cartilage. According to the study by Harvey et al., osteoarthritis, the most common form of arthritis, is the most common cause of joint function limitation among the elderly. Osteoarthritis is common in load-bearing joints and one of these joints is the knee joint. According to a study by Dawson et al, the rate of symptomatic knee and hip osteoarthritis in individuals over 65 years of age was reported to be 40%. In patients with gonarthrosis (knee osteoarthritis), lifestyle changes, drug therapy and rehabilitation are recommended in the early stages (Stages 1-2), while total knee arthroplasty comes to the fore in the later stages (Stages 3-4).

Orthopaedic surgery operating rooms are generally known as noisy working environments. Especially joint surgeries such as total knee arthroplasty and total hip arthroplasty have a close relationship with noise due to the cutting motors, hammers and osteophyte excision procedures used during surgery. This noise during surgery may be associated with anxiety and delayed onset of movement in the postoperative period.

It is thought that the sympathetic nervous system, which is activated as a result of anxiety, may cause delayed wound healing and delay in the return of functional activity with the release of stress hormones. The use of music as a medical treatment has gained importance in recent years. According to the study of Wu et al. it was observed that music in the environment during awake craniotomy decreased anxiety, pulse rate and blood pressure.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-03-15
• Study First Submitted: 2024-03-29
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Study First Posted: 2024-05-06
• Last Update Posted: 2024-05-06
• Primary Completion: 2025-01-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Patients diagnosed with stage 3-4 gonarthrosis
• Patients under spinal anaesthesia
• Patients undergoing unilateral knee replacement

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients who were played music during the operation	Music is played but noise is not cancelled	Patients who were played music that has been shown to reduce anxiety during surgery.
Patients who do not undergo noise cancellation during surgery	No noise cancellation and no music playing	Patients who do not undergo noise cancellation during knee replacement surgery
Patients undergoing noise cancellation during surgery	Noise cancelled but not allowed to listen to music	Patients undergoing noise cancellation with the help of an over the head earmuff with noise cancelling properties during knee replacement surgery

Primary Outcome Measures

Name	Time	Method
Knee Society Score Pre and Post-Operative	Pre-operative, Post-operative 3rd and 6th months	Patients will be scored preoperatively and postoperatively by measuring the Knee Society Score. Maximum 100 points, the higher the score, the better the results.

Secondary Outcome Measures

Name	Time	Method
The Oxford Knee Score	Pre-operative, Post-operative 3rd and 6th months	Patients will be scored preoperatively and postoperatively by measuring the The Oxford Knee Score. The Oxford Knee Score is frequently used to assess pain and functional limitations after knee arthroplasty, on a scale ranging from 0 to 48 (worst to best)
The Visual Analogue Scale	Postoperative 0-1-6-24-48-72 hours, 3rd week, 6th week, 3rd month, 6th month	The pain Visual Analogue Scale is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions, on a scale ranging from 0 to 10. A score of 0 indicates no pain, a score of 10 indicates the worst pain
Short Form 36	Preoperative, postoperative 6th month	The Short Form 36 is a multipurpose, short-form health survey including 36 questions particularly useful for comparing general and specific populations rather than individuals, score ranging from 0 to 100. Higher scores indicate better health status.
State-trait anxiety inventory STAI FORM TX-1	Pre-operative, Post-operative 1st day	The State-Trait Anxiety Inventory (STAI) is a widely used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and differentiate it from depressive syndromes. We used the STAI-TX1 State-Trait scale in our study. Scores range from 20 to 80, with higher scores correlating with greater anxiety.

Trial Locations

Locations (1)

Ankara City Hospital Bilkent; 🇹🇷 Ankara, Çankaya, Turkey