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

Ankara City Hospital

Status: Active, not recruiting

Conditions: Noise Exposure; Anxiety; Knee Osteoarthritis; Post Operative Pain

Treatments: Procedure: Noise cancelled but not allowed to listen to music; Procedure: No noise cancellation and no music playing; Procedure: Music is played but noise is not cancelled

Study type: Interventional

Funder types: Other

Identifiers

NCT06401018

TABED 1-24-81

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: Female

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Patients who do not undergo noise cancellation during surgery

Active Comparator group

Description:

Patients who do not undergo noise cancellation during knee replacement surgery

Treatment:

Procedure: No noise cancellation and no music playing

Patients undergoing noise cancellation during surgery

Active Comparator group

Description:

Patients undergoing noise cancellation with the help of an over the head earmuff with noise cancelling properties during knee replacement surgery

Treatment:

Procedure: Noise cancelled but not allowed to listen to music

Patients who were played music during the operation

Active Comparator group

Description:

Patients who were played music that has been shown to reduce anxiety during surgery.

Treatment:

Procedure: Music is played but noise is not cancelled