Knee OsteoarthritisTKANCT06401018
Comparison of Music and Ambient Noise Cancellation in Patients Undergoing Total Knee Arthroplasty (TKA)
A study testing No noise cancellation and no music playing, Noise cancelled but not allowed to listen to music and Music is played but noise is not cancelled in people with Knee Osteoarthritis and Anxiety, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Knee Osteoarthritis, Anxiety, Post Operative Pain
- What is being tested?
- No noise cancellation and no music playing, Noise cancelled but not allowed to listen to music and Music is played but noise is not cancelled
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with stage 3-4 gonarthrosis
- Patients under spinal anaesthesia
- Patients undergoing unilateral knee replacement
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Music and Ambient Noise Cancelling on Post-operative Pain, Anxiety and Functional Outcome During Total Knee Arthroplasty.
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?
Read more
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Anxiety, Post Operative Pain, Noise Exposure
- Being tested
- No noise cancellation and no music playing, Noise cancelled but not allowed to listen to music, Music is played but noise is not cancelled
- Keywords
- Total Knee Arthroplasty, Knee Replacement Surgery, Knee Osteoarthritis, Noise Cancelling, Ambient Noise, Post Operative Pain, Anxiety
- Medical subject headings
- Osteoarthritis, Knee, Anxiety Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No noise cancellation and no music playingProcedure or surgery
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 musicProcedure or surgery
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 cancelledProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients who do not undergo noise cancellation during surgery | Active comparator | Patients who do not undergo noise cancellation during knee replacement surgery Receives: 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 Receives: 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. Receives: Procedure: Music is played but noise is not cancelled |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-operative, Post-operative 3rd and 6th months
Secondary outcomes (4)
The Oxford Knee Score
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)
Measured: Pre-operative, Post-operative 3rd and 6th months
The Visual Analogue Scale
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
Measured: Postoperative 0-1-6-24-48-72 hours, 3rd week, 6th week, 3rd month, 6th month
Short Form 36
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.
Measured: Preoperative, postoperative 6th month
State-trait anxiety inventory STAI FORM TX-1
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.
Measured: Pre-operative, Post-operative 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start15 Mar 2024
- Primary completion15 May 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In our study, the patient population was divided into three groups according to the type of exposure to ambient noise during surgery.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güzelali Özdemir, Ankara City Hospital Bilkent
- Investigators
- Güzelali Özdemir, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401018
- Sponsor's protocol ID
- TABED 1-24-81
- Acronym
- TKA
- Status last verified
- Oct 2026
- First submitted
- 29 Mar 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32181048Kaur H, Saini N, Singh G, Singh A, Dahuja A, Kaur R. Music as an aid to Allay Anxiety in Patients Undergoing Orthopedic Surgeries under Spinal Anesthesia. Noise Health. 2022 Jan-Mar;24(112):7-12. doi: 10.4103/nah.nah_58_21.
PubMed 35645134Ligree N, Nanda S, Morwal S, Garg K. Effect of binaural beat music and noise cancelling headphones on intraoperative anxiety in patients undergoing spinal anaesthesia - A randomised controlled study. Indian J Anaesth. 2023 Jul;67(7):590-594. doi: 10.4103/ija.ija_740_22. Epub 2023 Jul 14.
PubMed 37601935Harvey 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.
PubMed 18687282Dawson 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.
PubMed 14762225Wu 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.
PubMed 28619305
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Music and Ambient Noise Cancelling on Post-operative Pain, Anxiety and Functional Outcome During Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT06401018
- Acronym / sponsor ID
- TKA / TABED 1-24-81
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- In our study, the patient population was divided into three groups according to the type of exposure to ambient noise during surgery.
| Arm | Type | Receives |
|---|---|---|
| Patients who do not undergo noise cancellation during surgery | Active comparator | Procedure: No noise cancellation and no music playingPatients who do not undergo noise cancellation during knee replacement surgery |
| Patients undergoing noise cancellation during surgery | Active comparator | Procedure: Noise cancelled but not allowed to listen to musicPatients undergoing noise cancellation with the help of an over the head earmuff with noise cancelling properties during knee replacement surgery |
| Patients who were played music during the operation | Active comparator | Procedure: Music is played but noise is not cancelledPatients who were played music that has been shown to reduce anxiety during surgery. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with stage 3-4 gonarthrosis
- Patients under spinal anaesthesia
- Patients undergoing unilateral knee replacement
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No noise cancellation and no music playingIn 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. | Procedure or surgery | Patients who do not undergo noise cancellation during surgery |
| Noise cancelled but not allowed to listen to musicIn this group of patients, only noise cancelling was performed during the operation, but no music was played in the environment. | Procedure or surgery | Patients undergoing noise cancellation during surgery |
| Music is played but noise is not cancelledIn 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. | Procedure or surgery | Patients who were played music during the operation |
Primary outcome
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.
4 secondary outcomes
The Oxford Knee Score
Time frame: Pre-operative, Post-operative 3rd and 6th months
The Visual Analogue Scale
Time frame: Postoperative 0-1-6-24-48-72 hours, 3rd week, 6th week, 3rd month, 6th month
Short Form 36
Time frame: Preoperative, postoperative 6th month
State-trait anxiety inventory STAI FORM TX-1
Time frame: Pre-operative, Post-operative 1st day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 32181048Tran 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.
- Background: PubMed 35645134Kaur H, Saini N, Singh G, Singh A, Dahuja A, Kaur R. Music as an aid to Allay Anxiety in Patients Undergoing Orthopedic Surgeries under Spinal Anesthesia. Noise Health. 2022 Jan-Mar;24(112):7-12. doi: 10.4103/nah.nah_58_21.
- Background: PubMed 37601935Ligree N, Nanda S, Morwal S, Garg K. Effect of binaural beat music and noise cancelling headphones on intraoperative anxiety in patients undergoing spinal anaesthesia - A randomised controlled study. Indian J Anaesth. 2023 Jul;67(7):590-594. doi: 10.4103/ija.ija_740_22. Epub 2023 Jul 14.
- Background: PubMed 18687282Harvey 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.
- Background: PubMed 14762225Dawson 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.
- Background: PubMed 28619305Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Güzelali Özdemir principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No noise cancellation and no music playing, Noise cancelled but not allowed to listen to music and Music is played but noise is not cancelled in people with Knee Osteoarthritis and Anxiety, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society Score Pre and Post-Operative (time frame: Pre-operative, Post-operative 3rd and 6th months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06401018, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.