Effect of a Music Intervention in Reducing Distress and Pain in Patients With Suspected or Diagnosed Lung Cancer Undergoing Mini-Invasive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Level of distress
研究概览
简要总结
This study aims at evaluating whether music therapy intervention is effective in decreasing psychological (distress) and physical symptoms (pain) in patients with suspected or diagnosed lung cancer undergoing minimally invasive lung surgery.
详细描述
A diagnosis of cancer may result in extensive emotional, physical and social suffering. Moreover, surgical treatment of lung cancer represents itself a stressful event. It is important that cancer care incorporates services that help meet patients' psychological, social and spiritual needs. Music therapy interventions have been used to alleviate symptoms and treatment side effects in cancer patients and their efficacy has been demonstrated in various settings. Within the distinction between music therapy (a personalized approach based on the interaction with a trained music therapist) and music medicine (with pre-recorded music), the best efficacy results have been reported with music therapy.
The use of music listening is growing in the field of music therapy intervention because of the impact musical contents can have on physiological, psychological and behavioural levels.
The primary objective of this study is to evaluate whether music therapy intervention is effective in decreasing psychological (distress) and physical symptoms (pain) in patients with suspected or diagnosed lung cancer undergoing minimally invasive lung surgery. Secondary objectives are the evaluation of the decrease of the serum cortisol as biomarker of stress and the request of additional doses of analgesics for pain control.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected or confirmed diagnosis of lung cancer
- •Age ≥ 18 years
- •Indication for lung resection through a minimally invasive surgery
- •Signed written informed consent
排除标准
- •Endocrinological disorders involving cortisol axis
- •Chronic steroid intake > 10 mg/day
- •Concomitant treatment with drugs against symptomatic anxiety and/or depression
- •Partial or complete hearing loss
- •Inability to follow the schedule of investigation
- •Patient unwilling to refrain from actively listening to other music (e.g., via other personal devices/headphones) outside of the prescribed musical intervention defined by the study protocol during the hospitalization.
研究组 & 干预措施
Arm A treated with classical music therapy and standard of care
Patients with suspected or diagnosed lung cancer undergoing minimally invasive lung resection will be treated with classical music therapy and standard of care.
干预措施: Music therapy intervention (Other)
Arm B treated with standard of care only
Patients with suspected or diagnosed lung cancer undergoing minimally invasive lung resection will be treated with standard of care only.
结局指标
主要结局
Level of distress
时间窗: From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)
Change of the level of distress on the Distress thermometer
Pain intensity
时间窗: From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery)
Change of pain intensity on the numerical scale
次要结局
- Additional doses of analgesics for pain control(From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery))
- Serum cortisol levels(From the day of surgery until the day of discharge from the hospital (in average 6 days after surgery))