NCT05981924已完成2 期
Effects of Music Therapy on Perioperative Anxiety and Pain Management in Lung Surgery: A Randomized, Prospective, Multidisciplinary Trial
Hao Long1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The total dose of oxycodone within 48 hours after surgery
研究概览
简要总结
To explore the feasibility and effectiveness of Perioperative Music Therapy Plus Oxycodone in pain management after thoracic surgery, patients will be randomly assigned into two groups. The experimental group will receive perioperative music therapy and the control group will not. We will record and contrast the postoperative oxycodone usage to evaluate the effect of music therapy in relieving the pain. We will also use visual analogue scale, questionnaire and EEG to evaluate patients' anxiety and depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enhanced CT or PET/CT indicate primary malignant pulmonary nodule;
- •The clinical stage belongs to cT1-4N0-2M0 before treatment or ycT1-4N0-2M0 after neoadjuvant treatment (AJCC/TNM 8th Edition);
- •Suitable for video-assisted thoracoscopic surgery after evaluated by thoracic surgeon;
- •FEV1 > 1.5L and DLCO > 60% pred;
- •Hearing loss lesser than 35 decibels (dB) in the better hearing ear;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;
- •American Society of Anesthesiologists Score of 1 or 2;
- •Confirmed eligibility for R0 resection for curative intent by thoracic surgeon assessment;
- •Adequate cardiopulmonary function, confirmed to meet the requirement for surgical resection for curative intent;
- •Able to provide written informed consent and able to understand and agree to comply with study requirements and evaluation forms;
- •Life expectancy greater than 12 months
排除标准
- •Enhanced CT or PET/CT indicate metastatic malignant pulmonary nodule;
- •Hearing loss greater than 35 decibels (dB) in the better hearing ear;
- •Active autoimmune disease or history of autoimmune disease that may recur; Note: well-controlled type 1 diabetes is allowed; hypothyroidism (controlled with thyroid hormone replacement only); well-controlled celiac disease; skin disease not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia); any other condition that is not expected to recur in the absence of an external trigger.
- •History of interstitial lung disease, pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease;
- •Serious infection occurred before grouping, including but not limited to hospitalization due to infectious complications, bacteremia or severe pneumonia; severe chronic or active infection (including pulmonary tuberculosis infection, etc.) requiring systemic (oral or intravenous) antibiotics within 14 days before grouping;
- •Simultaneous participation in another therapeutic clinical study;
- •Pregnant or lactating women, or male and female patients planning to have children during the study;
- •Other conditions that the investigators consider inappropriate for participation in this trial, such as poor compliance.
结局指标
主要结局
The total dose of oxycodone within 48 hours after surgery
时间窗: 48 hours after surgery
The total dose of oxycodone within 48 hours after surgery
次要结局
- The VSA-P Score(From the first day to the third day after surgery)
- The incidence rate of analgesic related adverse reaction(48 hours after surgery)
- The usage of extra analgesics after surgery(48 hours after surgery)
- The quality of life after treatment(The third day after surgery)
- The VSA-A Score(From 1 day before surgery to the third day after surgery)
- The kind and usage of anesthetics for anesthesia induction and maintenance(During the surgery)
- The press times of PCIA pump within 48 hours after surgery(48 hours after surgery)
研究者
Hao Long
Prof.
Sun Yat-sen University
研究点 (1)
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