Intraoperative Music Therapy for the Reduction of Postoperative Pain in Patients Undergoing an Enhanced Recovery After Surgery Protocol in Gynecological Oncology : A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The reduction in postoperative pain in patients undergoing gynecological oncology surgery within the ERAS protocol with the use of music therapy.
研究概览
简要总结
Background Perioperative anxiety and postoperative pain can impact surgical morbidity. We aimed to evaluate the effect of intraoperative music therapy in the reduction of immediate postoperative pain in patients undergoing gynecological oncology surgery within an Enhanced Recovery After Surgery (ERAS) protocol. Secondary objectives include reduction in preoperative anxiety, postoperative pain overtime, neurohormonal response, morbidity, length of hospital stay (LOS) and patient satisfaction.
Methods Prospective, randomized, double-blinded single-center study including patients undergoing surgery for ovarian, endometrial or cervical cancer over a period of 12 months. Patients were randomly assigned to receiving intraoperative music therapy (Group A) or undergoing standard management (Group B). A reduction in immediate postoperative pain was defined as a reduction in ≥2 points in the Verbal Rating Scale(VRS) at 4h postoperatively. Hemodynamic variables and blood samples were collected during the procedure for determination of cortisol levels. A scale of closed numeric questions (Likert-like) was used to assess patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Music therapy was administered before initiating anesthetic induction with the patient lying flat on the surgical table. A pair of non-reusable headphones (Disok, Alicante, Spain) were used in both groups which were connected to a tablet Fire 7 (Amazon, Seattle, WA, US) that was used as a music player device connected to Spotify. Two music lists were downloaded and reproduced without the need of access to WIFI to ensure good reproducibility. Group A was played a list consisting of rhythmic tones of 60-80bpm, music from the Seatwork 60bpm playlist with a duration of 11h and 5 minutes. Group B was played an empty playlist. Volume was set at a standard of 68dB. The surgical supervisor was responsible for opening the opaque envelope for each patient and to play the list according to the allocated group. Only the surgical supervisor knew the allocation for each patient, the rest of the surgical team were blinded to the allocation result.
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
- •All patients undergoing gynecological oncology surgery for ovarian, endometrial or cervical cancer by laparotomy, laparoscopy or robotic surgery.
- •ASA grade I-III
- •Signed an informed consent prior to inclusion
排除标准
- •Active ischemic cardiopathy
- •Hearing impairment
- •Hormonal disfunction
- •Active treatment with steroids
- •Ppsychiatric disorder
- •Contraindication for epidural anesthesia or failure of the technique in the peri-operative period.
结局指标
主要结局
The reduction in postoperative pain in patients undergoing gynecological oncology surgery within the ERAS protocol with the use of music therapy.
时间窗: 1 year
The main objective of this study was to evaluate the reduction in postoperative pain, defined as a reduction in two or more points in the VRS, in patients undergoing gynecological oncology surgery within the ERAS protocol with the use of music therapy. VRS is verbal rating score is a numeric rating scale (NRS-11) is an 11-point scale for patient self-reporting of pain. 0 means you have no pain; one to three means mild pain; four to seven is considered moderate pain; eight and above is severe pain.
次要结局
未报告次要终点