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临床试验/NCT07155837
NCT07155837Enrolling By Invitation不适用

The Effect of TENS on Early Patient Outcomes After Total Knee Arthroplasty

Cukurova University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
44
试验地点
1
主要终点
Initial 24-hour pain assessment with the Revised American Pain Society Patient Outcomes Questionnaire (GGAADHSA).

研究概览

简要总结

The Effect of TENS on Early Outcomes in Incisional Wounds After Total Knee Replacement Incisional wounds heal within 3 to 4 weeks, consistent with the normal healing process.

However, pain is experienced during the wound healing phase, which can negatively impact patients' recovery. Pharmacological and non-pharmacological methods are used to control pain in the early postoperative period. TENS, in particular, is notable as a non-invasive method, aiming to alleviate pain with low-voltage electrical currents. Studies report that TENS significantly reduces postoperative incisional wound pain. However, the literature demonstrates a limited number of studies on comprehensive pain assessment of incisional wounds using TENS. However, because postoperative incision pain negatively impacts patient outcomes (e.g., pain, mobilization, coughing, sleep), the effectiveness of the analgesia method must be measured. Early pain should be comprehensively assessed to plan effective treatments and improve patient recovery. In this context, the aim of the study was to evaluate the effect of TENS on early pain management in incisional wounds after total knee replacement. The study was designed as a randomized controlled trial. Patients meeting the study's sample criteria will be included. Data collection tools will be a Personal Information Form and the Revised American Pain Society Patient Outcomes Questionnaire (GGAADHSA), which measures the patient's pain assessment in the first 24 hours. TENS will be applied twice (12 hours apart) for 30 minutes each time within the first 24 hours after surgery to the experimental group, while the control group will receive standard treatment. The GGAADHSA questionnaire will be administered once to both groups 24 hours later. The study will evaluate the effect of TENS on early patient outcomes in incisional wounds and contribute to clinical practice in terms of postoperative recovery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Prevention
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

  • •- Patients who are over 18 years of age, A first-time total knee arthroplasty, No psychological distress, Able to communicate effectively, No history of chronic pain, Oriented to person, place, and time, Physician-approved, and have no contraindications to TENS (no pacemaker, no arrhythmia, no epilepsy, etc.), Agree to participate in the study.

排除标准

  • •- Patients with metastatic disease, Alcohol, drug, or substance abuse, Have other incisions

研究组 & 干预措施

Kontrol Grubu

Experimental

干预措施: TENS group (Device)

结局指标

主要结局

Initial 24-hour pain assessment with the Revised American Pain Society Patient Outcomes Questionnaire (GGAADHSA).

时间窗: 12 ay

This questionnaire measures multidimensional patient outcomes such as pain intensity, impact of pain on daily life (mobilization, sleep, coughing, etc.), and satisfaction with analgesia.

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

Abdurrahman ACAR

Research Assistant

Cukurova University

研究点 (1)

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