Analgesia, Lung Cancer
Conditions
Keywords
Music Therapy, Anxiety, Quality of Life
Brief summary
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.
Interventions
Music therapist will play customized music in the perioperative period on the basis of oxycodone analgesia
Sponsors
Study design
Intervention model description
Patients will be randomly assigned into two groups, the experimental group will receive music therapy and oxycodone for the pain management after thoracic surgery. The control group will only use oxycodone to relief the pain.
Eligibility
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total dose of oxycodone within 48 hours after surgery | 48 hours after surgery | The total dose of oxycodone within 48 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The VSA-A Score | From 1 day before surgery to the third day after surgery | The Visual Analogue Scale-Anxiety Score at different observation point |
| The VSA-P Score | From the first day to the third day after surgery | The Visual Analogue Scale-Pain Score at different observation point |
| The incidence rate of analgesic related adverse reaction | 48 hours after surgery | The incidence rate of analgesic related adverse reaction within 72 hours after surgery |
| The usage of extra analgesics after surgery | 48 hours after surgery | The usage of extra analgesics after surgery, such as Parecoxib, Tramadol or Morphine |
| The quality of life after treatment | The third day after surgery | The quality of life assessed by questionnaire on the third day after surgery |
| The press times of PCIA pump within 48 hours after surgery | 48 hours after surgery | The press times of PCIA pump within 48 hours after surgery |
| The kind and usage of anesthetics for anesthesia induction and maintenance | During the surgery | The kind and usage of anesthetics for anesthesia induction and maintenance, such as Propofol, Sufentanil and Cisatracurium |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes of resting beta power of electroencephalography in the central brain areas by preoperative treatment | 1 hour before surgery | Changes of resting beta power of electroencephalography in the central brain areas by preoperative treatment |
| Changes of resting beta power of electroencephalography in the frontal midline brain areas by preoperative treatment | 1 hour before surgery | Changes of resting beta power of electroencephalography in the frontal midline brain areas by preoperative treatment |
Countries
China