Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401018
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-03-29
Brief Title:
Comparison of Music and Ambient Noise Cancellation in Patients Undergoing Total Knee Arthroplasty TKA
Sponsor:
Ankara City Hospital Bilkent
Organization:
Ankara City Hospital Bilkent
Study Overview
Official Title:
Comparison of the Effects of Music and Ambient Noise Cancelling on Post-operative Pain Anxiety and Functional Outcome During Total Knee Arthroplasty
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TKA
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 peoples 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
Does the blocking of music or ambient noise which is predicted to reduce anxiety reduce peoples 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None