NCT06262022招募中不适用
The Effect of Cold Application on Pain Level, Edema and Drainage Amount in Patients With Total Knee Arthroplasty: A Randomized Controlled Study
Karamanoğlu Mehmetbey University2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- pain level
研究概览
简要总结
In this study, we aimed to investigate the effect of cold application applied for 20 minutes every hour for 8 hours on the first day, second and third days after total hip arthroplasty with gel pads, on the pain level, edema and drainage amount of total hip arthroplasty patients. The main question[s]it aims to answer are:
- Is there a difference between the pain levels of patients in the control and cold application arms?
- Is there a difference between the knee edema of patients in the control and cold application arms?
- Is there a difference between the amount of drainage of patients in the control and cold application arms? This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT).
详细描述
- When the patient arrives at the service after TKA, cold application will begin with gel pads at 0 ºC and continue for eight hours. After TKA, cold application will continue for 20 minutes every hour between 08.00-16.00 on the 1st and 2nd day.
- After TKA, pain intensity will be evaluated and at the 6th, 24th and 48th hours.
- Knee circumference measurements for knee edema will be made before TKA and at the 24th and 48th hours after TKA.
- After being taken to bed after TKA, the amount of drainage will be measured at the 1st, 6th and 24th hours.
- In the first 24 hours and 24-48 hours after TKA. Analgesic consumption between hours will be recorded.
- Knee temperature will be measured before and after each cold application.
- Knee temperature will be measured before and after each cold application. Measurements of the control group will be made at the specified times in the cold application group. Cold application will not be applied to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and above,
- •Able to communicate verbally and in writing,
- •Turkish speaking,
- •TKA applied for the first time,
- •Unilateral total knee arthroplasty applied,
- •Spinal anesthesia applied,
- •Having a hemovac drainage catheter,
- •Without peripheral vascular disease,
排除标准
- •Revision total knee arthroplasty applied,
- •Bilateraltotal knee arthroplasty applied,
- •Those who use alcohol and substances,
- •TKA was performed for a reason other than knee osteoarthritis,
- •General anesthesia applied,
结局指标
主要结局
pain level
时间窗: After total knee arthroplasty, pain intensity will be evaluated at the 6th, 24th and 48th hours.
Pain level of patients will be measured after total knee arthroplasty ( Visual Analogue Scale (VAS) is a 10 cm ruler with "no pain" written on one end and "the worst possible pain" written on the other end. Patients mark the levels on the ruler according to their pain levels. 1-3 points on the scale are rated as mild, 4-6 points as moderate and 7-10 points as severe pain.)
次要结局
- amount of drainage(After being taken to bed after total knee arthroplasty, the amount of drainage will be measured at the 1st, 6th and 24th hours.)
- edema(Knee circumference measurements for knee edema will be made before total knee arthroplasty and at the 24th and 48th hours after total knee arthroplasty.)
研究者
Fatma GÖK
lecturer
Karamanoğlu Mehmetbey University
研究点 (2)
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