Perioperative Music Therapy Plus Oxycodone in Perioperative Management of Lung Surgery

Effects of Music Therapy on Perioperative Anxiety and Pain Management in Lung Surgery: A Randomized, Prospective, Multidisciplinary Trial

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Lung Cancer
• Intervention / Treatment: Other: Perioperative Music Therapy

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total dose of oxycodone within 48 hours after surgery	The total dose of oxycodone within 48 hours after surgery	48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The VSA-A Score	The Visual Analogue Scale-Anxiety Score at different observation point	From 1 day before surgery to the third day after surgery
The VSA-P Score	The Visual Analogue Scale-Pain Score at different observation point	From the first day to the third day after surgery
The incidence rate of analgesic related adverse reaction	The incidence rate of analgesic related adverse reaction within 72 hours after surgery	48 hours after surgery
The usage of extra analgesics after surgery	The usage of extra analgesics after surgery, such as Parecoxib, Tramadol or Morphine	48 hours after surgery
The quality of life after treatment	The quality of life assessed by questionnaire on the third day after surgery	The third day after surgery
The press times of PCIA pump within 48 hours after surgery	The press times of PCIA pump within 48 hours after surgery	48 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of resting beta power of electroencephalography in the central brain areas by preoperative treatment	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 frontal midline 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

Collaborators and Investigators

• Sponsor: Hao Long
• Collaborators: Sun Yat-sen University School of Art; Sun Yat-sen University Department of Psychology

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): January 20, 2024
• Study Completion (Actual): April 20, 2024

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Quality of Life; Anxiety; Music Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: A2023-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No