The Effects of Two Different Electrical Stimulation Methods on the Pain Intensity of the Patients Who Had Undergone Abdominal Surgery With a Midline Incision: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 主要终点
- Postoperative pain intensity
研究概览
简要总结
The purpose of this study is to determine the effects of transcutaneous electrical nerve stimulation (TENS) and transcutaneous acupoint electrical stimulation (TAES) on pain and analgesic drug consumption in patients who had undergone abdominal surgery with a midline incision. Evidence for the effects of and transcutaneous electrical stimulation on pain and analgesic consumption on patients undergoing abdominal surgery with severe pain experience and high levels of neuroendocrine stress response is uncertain.
详细描述
This research was conducted as a randomized controlled trial. 158 patients who had undergone abdominal surgery with diagnosis of gastric and colorectal cancer were assessed for eligibility. This research sample consisted of 48 patients who underwent abdominal surgery with a midline incision. The patients were randomized into three groups, the first intervention group, which used TENS (around the incision), the second intervention group, which used TAES (ST25, P6, ST36, Lİ4 acupuncture points) and the control group, which did not. Electric stimulation was performed at the 30th minute, second, 18th, 21st, 40th, and 45th hours after the operation. Pain scores and analgesic consumption were assessed in the first 48 hours after surgical intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- 是
入选标准
- •Patients who had an American Society of Anesthesiologists (ASA) score of I-II
- •Patients were aged over 18 years
- •Patients who could read and write Turkish
- •Patients who were scheduled to undergo elective abdominal surgery with a midline incision for a diagnosis of stomach or colorectal cancer
- •Patients without any impairment of vision, hearing or speech
排除标准
- •Patients who had a pacemaker
- •Patients whose skin integrity around the incision was degraded
- •Patients had a cognitive disorder, had a history of chronic pain, or were suffering from neurological, renal, cardiac or pulmonary disorders that could affect the test results
- •Patients with an opioid addiction
- •Patients those who had previously undergone electrical stimulation treatment
- •Morbidly obese subjects
- •Patients using psychoactive drugs
研究组 & 干预措施
TENS to around the incision
The Patient Controlled Analgesia infusion was started right after the surgery. TENS was applied to around the incision.
干预措施: TENS (Other)
TAES to the acupuncture points
The Patient Controlled Analgesia infusion was started right after the surgery. TAES was applied to acupuncture points.
干预措施: TAES (Other)
No stimulation
No stimulation was performed to the patients in the control group.
结局指标
主要结局
Postoperative pain intensity
时间窗: The pain levels were evaluated and compared within postoperative first 48 hours.
First Intervention Group: Electrical stimulation was implemented at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery. Second Intervention Group: Electrical stimulation was implemented at acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery. Control Group: No intervention was performed to the patients in the control group. The pain intensity of each groups' patients were recorded and compred at the post-operative 2, 18, 22, 42, and 46th hours. Pain intensity was evaluated with VAS. VAS with a range of 1-10 points was used while evaluating the pain intensity of all patients .The increase of the scale score shows that the pain intensity increases.
次要结局
- Antiemetic drug consumption(Antiemetic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours.)
- Nausea severity(The nausea severity of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours.)
- Analgesic drug consumption(Analgesic drug consumption of the patients was evaluated at the periods of 0-24 and 24-48 hours. Patients were assessed in postoperative first 48 hours.)
- Pulmonary function tests(Pulmonary function evaluations of the patients were performed at the 24th and 48th hours. Patients were assessed in postoperative first 48 hours.)
- Vomiting(Vomiting status of the patients were evaluated at the periods of 0-6, 6-24, 24-48 hours. Patients were assessed in postoperative first 48 hours.)
研究者
Bediye Oztas
Teaching Staff
Yuksek Ihtisas University