Clinical trial NCT05981924: Perioperative Music Therapy Plus Oxycodone in Perioperative Management of Lung Surgery
Official title: Effects of Music Therapy on Perioperative Anxiety and Pain Management in Lung Surgery: A Randomized, Prospective, Multidisciplinary Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Analgesia
Lung Cancer
Keywords: Music Therapy
Anxiety
Quality of Life
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University School of Art
name: Sun Yat-sen University Department of Psychology
First posted: 2023-08-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The total dose of oxycodone within 48 hours after surgery
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: The VSA-A Score
timeFrame: From 1 day before surgery to the third day after surgery
measure: The VSA-P Score
timeFrame: From the first day to the third day after surgery
measure: The incidence rate of analgesic related adverse reaction
timeFrame: 48 hours after surgery
measure: The usage of extra analgesics after surgery
timeFrame: 48 hours after surgery
measure: The kind and usage of anesthetics for anesthesia induction and maintenance
timeFrame: During the surgery
measure: The quality of life after treatment
timeFrame: The third day after surgery
measure: The press times of PCIA pump within 48 hours after surgery
timeFrame: 48 hours after surgery
Other outcomes:
measure: Changes of resting beta power of electroencephalography in the central brain areas by preoperative treatment
timeFrame: 1 hour before surgery
measure: Changes of resting beta power of electroencephalography in the frontal midline brain areas by preoperative treatment
timeFrame: 1 hour before surgery
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
citation: Palmer JB, Lane D, Mayo D, Schluchter M, Leeming R. Effects of Music Therapy on Anesthesia Requirements and Anxiety in Women Undergoing Ambulatory Breast Surgery for Cancer Diagnosis and Treatment: A Randomized Controlled Trial. J Clin Oncol. 2015 Oct 1;33(28):3162-8. doi: 10.1200/JCO.2014.59.6049. Epub 2015 Aug 17.
citation: Zhou W, Ye C, Wang H, Mao Y, Zhang W, Liu A, Yang CL, Li T, Hayashi L, Zhao W, Chen L, Liu Y, Tao W, Zhang Z. Sound induces analgesia through corticothalamic circuits. Science. 2022 Jul 8;377(6602):198-204. doi: 10.1126/science.abn4663. Epub 2022 Jul 7.