Perioperative Music Therapy Plus Oxycodone in Perioperative Management of Lung Surgery

NCT05981924 | Completed Phase 2

• 1 other identifier: A2023-003
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Lung Cancer

Keywords

Music Therapy; Anxiety; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The VSA-A Score

  From 1 day before surgery to the third day after surgery

• The VSA-P Score

  From the first day to the third day after surgery

• The incidence rate of analgesic related adverse reaction

  48 hours after surgery

• The usage of extra analgesics after surgery

  48 hours after surgery

• The kind and usage of anesthetics for anesthesia induction and maintenance

  During the surgery

Other Outcomes (2)

• 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

  1 hour before surgery

Study Arms (2)

Oxycodone with Perioperative Music Therapy

EXPERIMENTAL

Using perioperative music therapy plus oxycodone to manage the postoperative pain

Other: Perioperative Music Therapy

Oxycodone without Perioperative Music Therapy

NO INTERVENTION

Using oxycodone only to manage the postoperative pain

Interventions

Perioperative Music Therapy OTHER

Music therapist will play customized music in the perioperative period on the basis of oxycodone analgesia

Oxycodone with Perioperative Music Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hao Long: lead
• Sun Yat-sen University School of Art: collaborator
• Sun Yat-sen University Department of Psychology: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (2)

• 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.

  PMID: 26282640 BACKGROUND

• 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.

  PMID: 35857536 RESULT

MeSH Terms

Conditions

Agnosia; Lung Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Model Details: 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.

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: August 1, 2023
• Primary Completion: January 20, 2024
• Study Completion: April 20, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)