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临床试验/NCT04243967
NCT04243967已完成不适用

Music Therapy Pathway to Reduce Preoperative Anxiety in Patients Undergoing Total Laparoscopic Hysterectomy for Benign Disease: a Randomized Controlled Trial

Università degli Studi dell'Insubria1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年2月1日最近更新:
适应症

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

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

发起方
Università degli Studi dell'Insubria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jvan Casarin

MD, Research Associate

Università degli Studi dell'Insubria

研究点 (1)

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