Effects of Transcutaneous Electrical Nerve Stimulation on Pain, Lymphedema, Upper Extremity Functions, and Quality of Life in Patients Undergoing Breast Surgery After Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
The aim of this randomized controlled trial was to evaluate the effects of transcutaneous electrical nerve stimulation (TENS) on postoperative pain, lymphedema development, shoulder range of motion, and quality of life in women undergoing breast cancer surgery after neoadjuvant chemotherapy. The main questions it aims to answer are:
Does TENS reduce postoperative pain? Does TENS prevent postoperative lymphedema? Does TENS increase postoperative shoulder range of motion? Does TENS improve postoperative quality of life? The researchers will compare the effects of TENS after breast surgery with a control group.
Participants will be assessed for pain, lymphedema development, and shoulder range of motion before surgery, on the first day after surgery, at the first month after surgery, and at the third month after surgery. Quality of life will be assessed before surgery, at the first month after surgery, and at the third month after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Those whose primary cancer tissue is breast
- •ASA classification is between I and III
- •Having unilateral breast surgery
排除标准
- •Those with cardiac problems and those using a pacemaker
- •Cognitively impaired
- •Disruption of skin integrity in the TENS application area
研究组 & 干预措施
TENS group
Patients in this group will receive TENS treatment for 1 month after surgery.
干预措施: TENS (Device)
Control group
Patients in this group do not receive TENS application after surgery.
结局指标
主要结局
Pain intensity
时间窗: Until the end of 3 month
The Visual Analog Scale (VAS) scale will be used to assess pain intensity. It is a 10 cm line with connecting expressions on the left (no pain) and on the right (extreme pain). The patient is asked to mark the current pain level on the line. It means that the pain intensity increases as you move from left to right.
Lymphedema severity
时间窗: Until the end of 3 month
A tape measure will be used to assess the severity of lymphedema. Measurements will be made bilaterally at 6 different points (Hand circumference, wrist, 15 cm below the elbow, 7,5 cm below the elbow, 7,5 cm above the elbow, 15 cm above the elbow )on the arm.
Shoulder and arm mobility
时间窗: Until the end of 3 month
Shoulder range of motion (flexion, extension, abduction, internal rotation and external rotation angles of the arm) was measured with a goniometer.
次要结局
- Upper extremity functions(Preoperative period, postoperative 1 month and postoperative 3 month)
- Cancer Related Quality of Life(Preoperative period, postoperative 1 month and postoperative 3 month)
研究者
Seda Akutay
Director
TC Erciyes University