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

Anxiety Clinical Trial

— TKA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06401018
• Other study ID #: TABED 1-24-81
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: September 15, 2025

Study information

• Verified date: May 2024
• Source: Ankara City Hospital Bilkent
• Contact: Güzelali Özdemir
• Phone: +90 532 584 36 11
• Email: drguzelali[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Knee Osteoarthritis
• Noise Exposure
• Osteoarthritis
• Osteoarthritis, Knee
• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital Bilkent	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

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. — View Citation

Kaur 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. — View Citation

Ligree 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Pre-operative, Post-operative 3rd and 6th months
Secondary	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	Postoperative 0-1-6-24-48-72 hours, 3rd week, 6th week, 3rd month, 6th month
Secondary	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.	Preoperative, postoperative 6th month
Secondary	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.	Pre-operative, Post-operative 1st day