Perioperative Music Therapy Plus Oxycodone in Analgesia After Thoracic Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study of Perioperative Music Therapy Plus Oxycodone in Analgesia After Thoracic Surgery

Conditions
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Analgesia, Lung Cancer

Intervention / Treatment
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* Other: Perioperative Music Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxycodone with Perioperative Music Therapy<br>Using perioperative music therapy plus oxycodone to manage the postoperative pain | Other: Perioperative Music Therapy<br>* Music therapist will play customized music in the perioperative period on the basis of oxycodone analgesia<br>|
| No Intervention: Oxycodone without Perioperative Music Therapy<br>Using oxycodone only to manage the postoperative pain | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total dose of oxycodone within 72 hours after surgery | The total dose of oxycodone within 72 hours after surgery | 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The VSA-A Score | The Visual Analogue Scale-Anxiety Score at different observation point | 1 day before surgery, 1 hour before surgery, 24/48/72 hours after surgery | 
| The VSA-P Score | The Visual Analogue Scale-Pain Score at different observation point | 24/48/72 hours after surgery | 
| The incidence rate of analgesic related adverse reaction | The incidence rate of analgesic related adverse reaction within 72 hours after surgery | 72 hours after surgery | 
| The usage of extra analgesics after surgery | The usage of extra analgesics after surgery, such as Parecoxib, Tramadol or Morphine | 72 hours after surgery | 
| The kind and usage of anesthetics for anesthesia induction and maintenance | The kind and usage of anesthetics for anesthesia induction and maintenance, such as Propofol, Sufentanil and Cisatracurium | During the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music Therapy, Anxiety, Quality of Life