Clinical trial NCT06401018: Comparison of Music and Ambient Noise Cancellation in Patients Undergoing Total Knee Arthroplasty (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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In our study, the patient population was divided into three groups according to the type of exposure to ambient noise during surgery.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Society Score Pre and Post-Operative
timeFrame: Pre-operative, Post-operative 3rd and 6th months
Secondary outcomes:
measure: The Oxford Knee Score
timeFrame: Pre-operative, Post-operative 3rd and 6th months
measure: The Visual Analogue Scale
timeFrame: Postoperative 0-1-6-24-48-72 hours, 3rd week, 6th week, 3rd month, 6th month
measure: Short Form 36
timeFrame: Preoperative, postoperative 6th month
measure: State-trait anxiety inventory STAI FORM TX-1
timeFrame: Pre-operative, Post-operative 1st day
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital Bilkent
state: Çankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Güzelali Özdemir
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.
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.