The Effect of Respiratory Exercise Using Preoperative Biofeedback on Postoperative Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Total score of STAI(state-trait anxiety inventory)
研究概览
简要总结
This study is a multi-center, randomized, controlled, double-blinded, and parallel design study. A total of 106 patients were decided to be recruited considering a 10% dropout rate. Patients are randomizes to perform or not respiratory exercises using biofeedback device(ResCalm). The randomization numbers are generated using a computer-generated randomization code and are sealed in the opaque envelope until they are handed over to anesthesiologist in charge of patient management. Record patient preoperative t anxiety, postoperative pain, and pain medication use. Patient aged 19-64 yr, ASA class 1 or 2, and are scheduled for elective laparoscopic cholecystectomy are included. Patients who were unable to perform self breathing at regular intervals were excluded.
详细描述
- Assignment of experimental groups
Group A: Respiratory exercise using respiratory biofeedback device(ResCalm) is applied 2-3 times / day for 3 minutes until discharge from hospital and once in the recovery room before surgery.
Group B: General surgery schedule without control exercise.
All patients measure STAI(state trait anxiety inventory) at the operating room entrance on the day of surgery. 2. anesthesia methods Intravenous anesthesia is performed using the target injection concentration control method. As an anesthetic, propofol / remifentanil / rocuronium is used. The artificial ventilation method is a pressure-controlled ventilation method, which maintains an appropriate pressure and performs anesthesia. 3. postoperative care After anesthesia, the patient wakes up and transfers to the recovery room to encourage self-breathing exercise. After entering the recovery room, the patient's vital signs (average blood pressure, heart rate, oxygen saturation) and analgesic use are checked immediately before leaving.
The investigators check for the presence of pulmonary complications, visual analog scale (VAS), analgesic use, and hospital patient satisfaction for 24 hours 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
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged between 19 and 64 years of age with ASA class I, II who underwent regular laparoscopic cholecystectomy under general anesthesia.
排除标准
- •Seniors 65 years of age or older or minors under 19 years of age
- •ASA (American Society of Anesthesiologists) class ≥ III
- •Difficulties in proper cooperation with diseases such as Alzheimer dementia, cognitive disorders, and psychopathy
- •Patients with respiratory diseases such as Asthma, Pnuemonia
- •Patients with incomplete airway due to pulmonary resection, airway surgery, mouth or nose surgery
结局指标
主要结局
Total score of STAI(state-trait anxiety inventory)
时间窗: 20 minutes before the anesthesia started.
Preoperative anxiety state is measured using STAI(state-trait anxiety inventory): Total score of 40 questions. Each question is consisted as follows 1: not at all 2: a little 3: somewhat 4: very much so minimal: 40 maximum: 160
次要结局
- The rate of Pulmonary complication(24 hours after the anesthesia finished.)
- The score of pain(24 hours after the anesthesia finished.)
- Total amount of cumulative analgesics(24 hours after the anesthesia finished.)
研究者
BON WOOK KOO
assistnat professosr
Seoul National University Bundang Hospital