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临床试验/NCT06401018
NCT06401018进行中(未招募)不适用

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

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
90
试验地点
1
主要终点
Knee Society Score Pre and Post-Operative

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

The investigator who evaluates the trial will not know which method has been used on which patient, and will be blinded.

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Knee Society Score Pre and Post-Operative

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Güzelali Özdemir

Professor

Ankara City Hospital Bilkent

研究点 (1)

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