Perioperative Music Therapy Plus Oxycodone in Perioperative Management of Lung Surgery

Hao Long

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Analgesia

Treatments

Other: Perioperative Music Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05981924

A2023-003

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.