Personalized Quantum Sonotherapy in Regional Anesthesia Peripheral Nerve Block: Randomized and Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
The objetive of the study is to evaluate the effect of personalized quantum sonotherapy on the level of anxiety and pain in outpatients schedule for orthopedic surgery under regional anesthesia in a second level center. The investigators believed that personalized quantum sonotherapy could reduce the levels of anxiety and pain before and after surgery evaluated through hemodynamic variables and scales for pain (analogous visual scale) and anxiety (STAI Spielberger anxious state questionnaire).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for elective orthopedic ambulatory surgery under regional anesthesia
- •Age between 18 and 60 years.
- •Patients with anesthetic risk ASA 1 and
- •Patients without contraindications for the administration of opioids and benzodiazepines.
- •Patients living in the metropolitan area who have a telephone line and can be contacted by telephone within the first 48 hours through calls at 24 and 48 hours after surgery, made by the researchers at the number previously reported by the patient.
- •Patients with an adequate level of understanding, who are able to communicate by telephone and understand a numerical scale.
- •Patients who agree to participate in the work.
排除标准
- •Patients with auditory and cognitive problems.
- •Patients requiring general anesthesia at some time during the intraoperative period.
- •Patients with morbid obesity.
- •Patients consuming anxiolytics in the last month.
- •Patients whose start of surgery is after 45 minutes of the blockade.
结局指标
主要结局
Pain
时间窗: 48 hours (From the moment before surgery when the sonotherapy is apply until 48 hours after surgery)
To assess the effect of personalized quantum sonotherapy on the level of pain of patients taken to orthopedic surgery under regional anesthesia through pain score visual analoge score (VAS). VAS ranges from 0 to 10 being 0 no pain an 10 the worst pain ever felted. It would be measured before and after placing de sonotherapy, 24 and 48 hour after surgery.
Anxiety
时间窗: 48 hours (From the moment before surgery when the sonotherapy is apply until 48 hours after surgery)
To assess the effect of personalized quantum sonotherapy on the level of anxiety of patients taken to orthopedic surgery under regional anesthesia through anxiety score Questionnaire of anxious state STAI (Spielberger). STAI is a score to meausre anxiety, it has 20 questions each one with a possible value from 0 to 3 points. Total score is evaluated adding each score for each question, and it goes from 0 to 60 points, being 60 de higest score for anxiety. It would be measured before and after placing de sonotherapy, 24 and 48 hour after surgery.
次要结局
未报告次要终点
研究者
Ana Sofia Arango Gutierrez
Medical Doctor
CES University