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临床试验/NCT06393075
NCT06393075尚未招募不适用

Effect of Preoperative Combined Care Guidance on Pain, Anxiety and Joint Range of Motion in Patients Undergoing Total Knee Arthroplasty

Taipei Veterans General Hospital, Taiwan2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
2
主要终点
pain scores

研究概览

简要总结

The goal of this clinical trial is to compare the effectiveness of combined care guidance and general care guidance on pain scores, anxiety levels and joint mobility in patients undergoing total artificial knee replacement. The main questions it aims to answer are:

  • Does combined care coaching reduce patient pain scores and anxiety levels after surgery?
  • Does combined care guidance improve knee joint mobility after surgery? Researchers will compare combined care guidance and general care to see if combined care guidance reduces patients' pain scores and anxiety levels after surgery, and improves knee joint mobility after surgery.

Participants will:

  • Watch pain and rehabilitation exercise guidance videos before surgery and learn how to use a walker.
  • Complete questionnaires before surgery, 24 hours, 48 hours, 72 hours and three months after surgery.
  • Questionnaire records pain level, anxiety level and joint mobility.

详细描述

Background:The population is aging rapidly, and an aging society is approaching. According to Taiwan government statistics, the population over 65 years old has reached 16.2%. The number of people suffering from knee osteoarthritis has reached 860,000, and the number of patients undergoing total artificial knee replacement has reached 29,000. people.Artificial knee replacement can effectively relieve joint pain, correct joint deformities, and improve joint function. However, patients who undergo total artificial knee replacement still experience moderate to severe pain after surgery. Effective pain control can promote early rehabilitation and early ambulation of patients. In clinical practice, it is more common to provide a single interventional measure to improve the pain level after surgery, but less to provide combined measures before surgery, which leads to the motivation for discussion.

Purpose:To compare the effectiveness of combined care guidance and general care Method:guidance on pain scores, anxiety levels and joint mobility of patients undergoing total artificial knee replacement before surgery, 24 hours, 48 hours, 72 hours and three months after surgery.Experimental group: Researchers provided combined care, watched animated videos, demonstrated rehabilitation exercises and practiced walking using walkers.Control group: The researchers provided general preoperative care and demonstrated rehabilitation exercises and the use of walking aids after surgery.

:This study adopted an experimental research design, single-blind, and randomly assigned groups, one experimental group and one control group.Data were collected five times in total, before surgery, 24 hours after surgery, 48 hours after surgery, 72 hours after surgery and 3 months after surgery.All five data collections are required to fill in the Numerical Rating Scale (NRS) state-trait anxiety inventory (STAI), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

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
Single (Participant)

入排标准

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

入选标准

  • Those who are 20 years old or above (inclusive), have undergone unilateral total knee replacement for the first time, have clear consciousness, can speak Mandarin and Taiwanese, have elementary school-level reading ability, and are willing to participate in the study

排除标准

  • Patients with bilateral total knee replacement, osteoarthritis tumors, rheumatoid arthritis, who are unable to cooperate with interventional measures, patients with dementia or cognitive dysfunction who are unable to cooperate; those who are participating in other pain control studies

结局指标

主要结局

pain scores

时间窗: baseline, 24 hours, 48 hours, 72 hours and three months after surgery

Using the Numerical Rating Scale to assess postoperative pain in patients undergoing knee replacement surgery.0 points are not painful, 10 points are the most painful.

joint mobility

时间窗: baseline, 24 hours, 48 hours, 72 hours and three months after surgery

Assessment of range of motion after knee surgery using the Western Ontario and McMaster Universities Osteoarthritis Index.

anxiety levels

时间窗: baseline, 24 hours, 48 hours, 72 hours and three months after surgery

Assessing Anxiety Levels After Knee Replacement Using the State-Trait Anxiety Inventory.Scale scores range from 20 to 80, with lower scores indicating less severe anxiety, 20-39 indicating mild anxiety, 40-59 indicating moderate anxiety, and 60-80 indicating severe anxiety.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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