Role of Transcutaneous Electrical Nerve Stimulation in Pain Relief and Pulmonary Function in Patients Undergoing Bariatric Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- As a primary endpoint, pain using the visual analog pain scale.
研究概览
简要总结
It is a consensus in the literature that changes in lifestyle and carbohydrate-rich diet are part of a context that has led to an obesity pandemic. Its treatment is multidisciplinary, however, in many cases, conventional therapy has no effect, requiring surgical intervention. The latter, in turn, is not free of risks and causes important changes in lung function. Therefore, this study aims to evaluate the effect of electroanalgesia through conventional transcutaneous nerve stimulation (TENS) on pulmonary function in the postoperative period of bariatric surgery.
详细描述
This is an uncontrolled cross-sectional clinical trial with a sample of 66 individuals between 18 and 50 years of age in a hospital in the West of Paraná. Pain assessment will be performed through analogue pain scale, pulmonary function through spirometry and respiratory muscle strength through manovacuometry. Four TENS applications will be performed for a period of 30 minutes. Through this research, it is expected that the patients who perform TENS present a reduction in postoperative pain and, consequently, a lower impact on lung function.
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
- None
盲法说明
He sample will consist of 132 individuals, of both men and women, where they will be randomly included in two groups: 1) Intervention group composed of 66 patients who will effectively receive the treatment through electroanalgesia via TENS; and 2) Control Group, which will also consist of 66 individuals; however, they will not be subjected to electroanalgesia. For division of groups, a sortition will be carried out through envelopes where it will be decided to which study group the patient will be allocated.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •This research will include patients who are in the postoperative period of bariatric surgery and who are aged 18 years or over
排除标准
- •Patients over the age of 50;
- •Individuals who present hemodynamic instability in the postoperative period;
- •Use of mechanical ventilation for more than 24 hours;
- •Contraindications regarding the use of TENS (presence of a cardiac pacemaker, hypersensitivity regarding the use of TENS);
- •Previous history of epilepsy;
- •Pregnant women during the first trimester;
- •Patients with a score, on the Glasgow coma scale (Appendix I), less than 15;
- •Patients who choose to withdraw during the study.
结局指标
主要结局
As a primary endpoint, pain using the visual analog pain scale.
时间窗: 5 days.
This scale is considered valid to predict the level of pain in the postoperative period of bariatric surgery. The value being zero without pain and ten maximum pain.
次要结局
- Evaluate changes in the strength of respiratory muscles, using manovacuometry.(5 days.)
- To evaluate lung function in patients in the postoperative period of bariatric surgery using spirometry.(5 days.)