Perioperative Music Therapy Plus Oxycodone in Perioperative Management of Lung Surgery

Phase 2

Completed

• Conditions: Lung Cancer; Analgesia
• Interventions: Other: Perioperative Music Therapy

• Registration Number: NCT05981924
• Lead Sponsor: Hao Long

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Study Start: 2023-08-01
• Study First Posted: 2023-08-08
• Primary Completion: 2024-01-20
• Study Completion: 2024-04-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone with Perioperative Music Therapy	Perioperative Music Therapy	Using perioperative music therapy plus oxycodone to manage the postoperative pain

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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
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

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China