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NCT Number: NCT06401018

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Knee Osteoarthritis Anxiety Anxiety Disorders Arthritis Joint Diseases Mental Disorders Musculoskeletal Diseases Neurologic Manifestations Noise Exposure Osteoarthritis Osteoarthritis, Knee Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Rheumatic Diseases Signs and Symptoms

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital Bilkent

Ankara, Çankaya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No noise cancellation and no music playing

Procedure

In this group of patients, no apparatus was used to prevent noise in the environment, and they were not exposed to any music in the environment.

Noise cancelled but not allowed to listen to music

Procedure

In this group of patients, only noise cancelling was performed during the operation, but no music was played in the environment.

Music is played but noise is not cancelled

Procedure

In this group of patients, ambient noise cancelling was not applied and music, which has been proven to reduce anxiety in studies, was played during surgery.

Primary outcomes

  1. Knee Society Score Pre and Post-Operative

    Time frame: 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 outcomes

  1. The Oxford Knee Score

    Time frame: 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)

  2. The Visual Analogue Scale

    Time frame: 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

  3. Short Form 36

    Time frame: 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.

  4. State-trait anxiety inventory STAI FORM TX-1

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Comparison of the Effects of Music and Ambient Noise Cancelling on Post-operative Pain, Anxiety and Functional Outcome During Total Knee Arthroplasty.

Acronym: TKA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 6, 2024
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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