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

NCT06401018 | Active Not Recruiting

• 1 other identifier: TABED 1-24-81
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Anxiety; Post Operative Pain; Noise Exposure

Keywords

Total Knee Arthroplasty; Knee Replacement Surgery; Knee Osteoarthritis; Noise Cancelling; Ambient Noise; Post Operative Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• Knee Society Score Pre and Post-Operative

  Patients will be scored preoperatively and postoperatively by measuring the Knee Society Score. Maximum 100 points, the higher the score, the better the results.

  Pre-operative, Post-operative 3rd and 6th months

Secondary Outcomes (4)

• The Oxford Knee Score

  Pre-operative, Post-operative 3rd and 6th months

• The Visual Analogue Scale

  Postoperative 0-1-6-24-48-72 hours, 3rd week, 6th week, 3rd month, 6th month

• Short Form 36

  Preoperative, postoperative 6th month

• State-trait anxiety inventory STAI FORM TX-1

  Pre-operative, Post-operative 1st day

Study Arms (3)

Patients who do not undergo noise cancellation during surgery

ACTIVE COMPARATOR

Patients who do not undergo noise cancellation during knee replacement surgery

Procedure: No noise cancellation and no music playing

Patients undergoing noise cancellation during surgery

ACTIVE COMPARATOR

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

Procedure: Noise cancelled but not allowed to listen to music

Patients who were played music during the operation

ACTIVE COMPARATOR

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

Procedure: Music is played but noise is not cancelled

Interventions

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.

Patients who do not undergo noise cancellation during surgery

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.

Patients undergoing noise cancellation during surgery

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.

Patients who were played music during the operation

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital Bilkent

Ankara, Çankaya, Turkey (Türkiye)

Location

Related Publications (6)

• Tran BW, Nowrouz MY, Dhillon SK, Xie KK, Breslin KM, Golladay GJ. The Impact of Music and Noise-Cancellation on Sedation Requirements During Total Knee Replacement: A Randomized Controlled Trial. Geriatr Orthop Surg Rehabil. 2020 Mar 4;11:2151459320910844. doi: 10.1177/2151459320910844. eCollection 2020.

  PMID: 32181048 BACKGROUND

• Skaugen P. Bacillus Calmette-Guerin therapy for bladder carcinoma in situ: use in a clinical setting. Urol Nurs. 1997 Jun;17(2):69-71. No abstract available.

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• Laine C, Markson LE, Fanning TR, Turner BJ. Relationship between ambulatory care accessibility and hospitalization for persons with advanced HIV disease. J Health Care Poor Underserved. 1999 Aug;10(3):313-27. doi: 10.1353/hpu.2010.0633.

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• Harvey WF, Hunter DJ. The role of analgesics and intra-articular injections in disease management. Rheum Dis Clin North Am. 2008 Aug;34(3):777-88. doi: 10.1016/j.rdc.2008.05.006.

  PMID: 18687282 BACKGROUND

• Dawson J, Linsell L, Zondervan K, Rose P, Randall T, Carr A, Fitzpatrick R. Epidemiology of hip and knee pain and its impact on overall health status in older adults. Rheumatology (Oxford). 2004 Apr;43(4):497-504. doi: 10.1093/rheumatology/keh086. Epub 2004 Feb 3.

  PMID: 14762225 BACKGROUND

• Wu PY, Huang ML, Lee WP, Wang C, Shih WM. Effects of music listening on anxiety and physiological responses in patients undergoing awake craniotomy. Complement Ther Med. 2017 Jun;32:56-60. doi: 10.1016/j.ctim.2017.03.007. Epub 2017 Mar 31.

  PMID: 28619305 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Anxiety Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Güzelali Özdemir

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator who evaluates the trial will not know which method has been used on which patient, and will be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: May 6, 2024
• Study Start: March 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: September 15, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)