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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2025-09-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Knee Osteoarthritis Anxiety Post Operative Pain Noise Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In our study, the patient population was divided into three groups according to the type of exposure to ambient noise during surgery.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

The investigator who evaluates the trial will not know which method has been used on which patient, and will be blinded.

Study Groups

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Patients who do not undergo noise cancellation during surgery

Patients who do not undergo noise cancellation during knee replacement surgery

Group Type ACTIVE_COMPARATOR

No noise cancellation and no music playing

Intervention Type 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.

Patients undergoing noise cancellation during surgery

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

Group Type ACTIVE_COMPARATOR

Noise cancelled but not allowed to listen to music

Intervention Type PROCEDURE

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

Patients who were played music during the operation

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

Group Type ACTIVE_COMPARATOR

Music is played but noise is not cancelled

Intervention Type 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.

Interventions

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No noise cancellation and no music playing

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.

Intervention Type PROCEDURE

Noise cancelled but not allowed to listen to music

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

Intervention Type PROCEDURE

Music is played but noise is not cancelled

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No