跳至主要内容
临床试验/NCT06914323
NCT06914323进行中(未招募)不适用

The Effects of Acupressure on Pain, Swelling and Comfort in Patients With Femoral Fracture Surgery

Hungkuang University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年2月18日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
140
试验地点
1
主要终点
Changes in pain

研究概览

简要总结

Pain is a subjective and unpleasant sensory and emotional experience associated with actual or potential tissue damage. Fractures result from a disruption in the continuity of bone, where bones are subjected to traction, twisting, or compression, causing damage to the surrounding muscular tissues. The treatment of displaced or complex fractures typically requires internal fixation surgery. 89% of fracture patients experience postoperative pain and swelling by the second day following open reduction and internal fixation surgery. These negative sensations can lead to increased pain, limb deformity, and neurovascular compression injuries. If postoperative pain is not adequately managed, it can affect wound healing, increase metabolism and oxygen consumption, and place additional strain on cardiopulmonary function. It is necessary to integrate alternative, non-pharmacological, non-invasive pain relief measures. Effectively and safely alleviating acute postoperative pain can enhance comfort, promote early mobilization, improve adherence to postoperative physical therapy, enhance quality of life and shorten hospital stays.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • The patient was hospitalized due to injuries from an accident, diagnosed with unilateral femoral fracture and underwent open reduction internal fixation surgery, hemiarthroplasty, and total hip arthroplasty.
  • Adults aged 18 years or older.
  • Conscious and able to communicate in Mandarin or Taiwanese (Min Nan).
  • Intact and without missing lower limbs.
  • Willing to sign the informed consent form after being briefed on the study objectives and procedures.

排除标准

  • Diagnosis of musculoskeletal tumors.
  • History of cerebrovascular accident or peripheral vascular neuropathy.
  • Major medical conditions such as cirrhosis, renal failure, heart failure, cancer, and severe brain diseases.
  • Edema caused by nutritional deficiency or mucinous causes.
  • Pregnant or lactating women.
  • Patients using patient-controlled analgesia post-surgery.
  • Severe psychiatric disorders or perceptual disorders.
  • Platelet count less than 20 x 10^3/uL before screening.
  • Albumin less than 3.5g/dL before screening.
  • Individuals closely related to the trial personnel, such as immediate family or dependents of the principal investigator.

结局指标

主要结局

Changes in pain

时间窗: post op day 1 to post op day 2

Pain is measured using the Visual Analog Scale (VAS). The left end is labeled as "no pain," which represents 0, and the right end as "the most severe pain imaginable," which represents 100.

Change in limb swelling

时间窗: post op day 1 to post op day 2

Foot circumference at the midpoint of the line connecting the fifth toe to the lateral malleola is measured in centimeters for swelling assessment. A measuring tape is used. During the measurement, the patient is positioned in a supine posture.

Changes in patient comfort

时间窗: post op day 1 to post op day 2

Shortened General Comfort Questionnaire (SGCQ) for measuring comfort. The questionnaire consists of 28 items, assessed on a 6-point Likert scale ranging from "strongly disagree" to "strongly agree." A score of 1 represents "strongly disagree," while a score of 6 represents "strongly agree." The total score ranges from 28 to 148, with higher scores indicating greater levels of comfort.

次要结局

未报告次要终点

研究者

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

Yu-Tzu Chang

Nurse practitioner

Hungkuang University

研究点 (1)

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