Music Therapy Pathway to Reduce Preoperative Anxiety in Patients Undergoing Total Laparoscopic Hysterectomy for Benign Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Anxiety
研究概览
简要总结
Music therapy is a non-invasive, safe, and inexpensive intervention that can be easily and successfully delivered. it has been shown that music therapy might reduce the postoperative pain in patients undergoing cesarean section and in those with cancer, showing a lower state of anxiety and greater pain reduction in participants who received music interventions.
The aim of the present study is to investigate the role of music and music therapy on anxiety and perception of pain in patients undergoing elective hysterectomy for benign disease.
详细描述
Hysterectomy is the second most common surgical procedure in the United States. Uterine fibroids (with or without the association of heavy menstrual bleeding) represent the primary indication for surgery. Prospective controlled trials have shown that the laparoscopic approach guarantees benefits in terms of perioperative surgical outcomes and better patients' quality of life if compared with open surgery. Music is a non-invasive, safe, and inexpensive intervention that can be delivered easily and successfully. Results of a recent meta-analysis of 73 RCTs demonstrated that music could be offered as a way to help patients reducing pain and anxiety during the postoperative period. Recently a prospective randomized trial demonstrated a reduction of anxiety also in patients undergoing gynecological minor procedures (office hysteroscopy). Thanks to the use of a validated scale for assessing the preoperative and postoperative level of anxiety (STAI: State-Trait Anxiety Inventory), an Italian group demonstrated an average reduction of approximately 5 points of STAI score in patients enrolled for listening to music before surgery compared to the control group (without music). Similarly, a RCT demonstrated that preoperative music intervention might also reduce the postoperative pain in patients undergoing cesarean section (reduction of 1.35 VAS points at 6 hours). A recent meta-analysis evaluated music interventions for improving psychological and physical outcomes in adult and pediatric patients with cancer, showing a lower state of anxiety and greater pain reduction in participants who received music interventions.
No study has been performed that aimed to investigate the role of music on anxiety and perception of pain in patients undergoing elective hysterectomy for benign disease, up to now.
A comparison with a superiority trial is required to evaluate the effects of music played preoperatively in women undergoing total laparoscopic hysterectomy for benign disease. Our findings will offer evidence in favor of the use of music therapy as a method to reduce perioperative anxiety and postoperative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 55 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women (45-55 years)
- •Scheduled for total laparoscopic hysterectomy (+/- salpingectomy or salpingo-oophorectomy)
- •Indication for surgery: presumed benign gynecologic disease
排除标准
- •Any other associated non-gynecologic procedure to hysterectomy
- •History of previous malignancy
- •Individuals with hearing impairment (total or partial hearing difficulties)
- •Patients with neuropathic pain/chronic pain needing regular anti-inflammatory drugs
- •Non-Italian speaking patients
- •Inability to provide informed consent
- •Currently enrolled in any other research study involving drugs or devices
结局指标
主要结局
Anxiety
时间窗: At 1-month follow-up clinical evaluation
Late postoperative - HADS scale assessment
次要结局
- Pain (VAS)(8 hours after the end of the surgery)
研究者
Jvan Casarin
MD, Research Associate
Università degli Studi dell'Insubria
